+-----------------------+-----------------------+------+------+------+
| **Firm Name:**        |                       |      |      |      |
| **FEI Number:**       |                       |      |      |      |
|                       |                       |      |      |      |
| **Inspection          |                       |      |      |      |
| Date(s):**            |                       |      |      |      |
| **FCE Number:**       |                       |      |      |      |
|                       |                       |      |      |      |
| **Investigators:**    |                       |      |      |      |
|                       |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| DEPARTMENT OF HEALTH  |                       |      |      |      |
| AND HUMAN SERVICES    |                       |      |      |      |
|                       |                       |      |      |      |
| FOOD AND DRUG         |                       |      |      |      |
| ADMINISTRATION        |                       |      |      |      |
|                       |                       |      |      |      |
| **FDA LACF INSPECTION |                       |      |      |      |
| REPORT**              |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| This inspection       |                       |      |      |      |
| report is available   |                       |      |      |      |
| in PDF and M.S. Word  |                       |      |      |      |
| on the forms site:    |                       |      |      |      |
| *http://w             |                       |      |      |      |
| ww.fda.gov/opacommore |                       |      |      |      |
| choic                 |                       |      |      |      |
| es/fdaforms/ora.html* |                       |      |      |      |
| (only the M.S. Word   |                       |      |      |      |
| version has           |                       |      |      |      |
| expandable fields).   |                       |      |      |      |
| Narrative responses   |                       |      |      |      |
| to each item can be   |                       |      |      |      |
| entered in the item's |                       |      |      |      |
| "comments" area or    |                       |      |      |      |
| where otherwise       |                       |      |      |      |
| prompted. Complete    |                       |      |      |      |
| documentation of      |                       |      |      |      |
| deficiencies          |                       |      |      |      |
| including deviations  |                       |      |      |      |
| from Part 113 should  |                       |      |      |      |
| be narrated with      |                       |      |      |      |
| reference to photos,  |                       |      |      |      |
| exhibits, etc, in the |                       |      |      |      |
| Turbo EIR under       |                       |      |      |      |
| "Objectionable        |                       |      |      |      |
| Conditions and        |                       |      |      |      |
| Management's          |                       |      |      |      |
| Response". When       |                       |      |      |      |
| necessary, refer the  |                       |      |      |      |
| reader to the         |                       |      |      |      |
| appropriate section   |                       |      |      |      |
| of the Turbo EIR for  |                       |      |      |      |
| a full explanation of |                       |      |      |      |
| details.              |                       |      |      |      |
|                       |                       |      |      |      |
| This form should be   |                       |      |      |      |
| downloaded from the   |                       |      |      |      |
| forms site to a       |                       |      |      |      |
| computer drive prior  |                       |      |      |      |
| to completion and     |                       |      |      |      |
| copying. The finished |                       |      |      |      |
| report should be      |                       |      |      |      |
| submitted as an       |                       |      |      |      |
| attachment to the     |                       |      |      |      |
| Turbo EIR.            |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **PROCESS             |                       |      |      |      |
| ESTABLISHMENT, FILING |                       |      |      |      |
| AND SCHEDULES**       |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 1.  HAS THE FIRM      |                       |      |      |      |
|     REGISTERED WITH   |                       |      |      |      |
|     FDA AND FILED A   |                       |      |      |      |
|     PROCESS FOR ALL   |                       |      |      |      |
|     LACFS PROCESSED   |                       |      |      |      |
|     AT THIS FACILITY, |                       |      |      |      |
|     AND FOR FOREIGN   |                       |      |      |      |
|     FIRMS, ALL        |                       |      |      |      |
|     PRODUCTS          |                       |      |      |      |
|     PROCESSED AND     |                       |      |      |      |
|     SHIPPED TO THE    |                       |      |      |      |
|     U.S.?             |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 2.  HAVE PROCESSES    |                       |      |      |      |
|     BEEN ESTABLISHED  |                       |      |      |      |
|     FOR ALL LACFS     |                       |      |      |      |
|     PROCESSED AT THIS |                       |      |      |      |
|     FACILITY? --      |                       |      |      |      |
|     113.83            |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 3.  LIST THE FIRM'S   |                       |      |      |      |
|     PROCESS           |                       |      |      |      |
|     AUTHORITIES:      |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 4.  ARE THE PROCESS   |                       |      |      |      |
|     AUTHORITIES THE   |                       |      |      |      |
|     SAME AS THAT      |                       |      |      |      |
|     FILED WITH FDA?   |                       |      |      |      |
|     Yes No            |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 5.  DOES THE FIRM     |                       |      |      |      |
|     HAVE A PROCESS    |                       |      |      |      |
|     LETTER OR OTHER   |                       |      |      |      |
|     PROCESS SOURCE    |                       |      |      |      |
|     DOCUMENTATION     |                       |      |      |      |
|     LISTING CRITICAL  |                       |      |      |      |
|     FACTORS NECESSARY |                       |      |      |      |
|     TO CONTROL IN THE |                       |      |      |      |
|     ATTAINMENT OF     |                       |      |      |      |
|     COMMERCIAL        |                       |      |      |      |
|     STERILITY?        |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 6\. DO CRITICAL       |                       |      |      |      |
| FACTORS/LIMITS LISTED |                       |      |      |      |
| IN SOURCE DOCUMENTS   |                       |      |      |      |
| MATCH CRITICAL        |                       |      |      |      |
| FACTORS/LIMITS FOR    |                       |      |      |      |
| SELECTED PRODUCTS AND |                       |      |      |      |
| PROCESSES FILED WITH  |                       |      |      |      |
| FDA? Yes No           |                       |      |      |      |
|                       |                       |      |      |      |
| *NOTE - CRITICAL      |                       |      |      |      |
| FACTORS MAY EXIST     |                       |      |      |      |
| WHICH THE FIRM        |                       |      |      |      |
| CONTROLS BUT HAVE NOT |                       |      |      |      |
| BEEN IDENTIFIED IN    |                       |      |      |      |
| THE PROCESS\          |                       |      |      |      |
| FILING AND/OR HAS     |                       |      |      |      |
| FAILED TO IDENTIFY    |                       |      |      |      |
| AND DOES NOT          |                       |      |      |      |
| CONTROL)*             |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 7\. HAVE FILED,       |                       |      |      |      |
| SCHEDULED PROCESSES   |                       |      |      |      |
| BEEN CHANGED IN SUCH  |                       |      |      |      |
| A WAY THAT COULD      |                       |      |      |      |
| AFFECT THE ATTAINMENT |                       |      |      |      |
| OF COMMERCIAL         |                       |      |      |      |
| STERILITY? Yes No     |                       |      |      |      |
|                       |                       |      |      |      |
| (THERE ARE MANY       |                       |      |      |      |
| FACTORS WHICH MAY     |                       |      |      |      |
| AFFECT HEAT           |                       |      |      |      |
| PENETRATION AND THE   |                       |      |      |      |
| ATTAINMENT OF         |                       |      |      |      |
| COMMERCIAL STERILITY; |                       |      |      |      |
| THESE FACTORS INCLUDE |                       |      |      |      |
| CONTAINER TYPE AND    |                       |      |      |      |
| POSITION, TYPE OF     |                       |      |      |      |
| HEATING MEDIUM,       |                       |      |      |      |
| PRODUCT FACTORS SUCH  |                       |      |      |      |
| AS FILL WEIGHT,       |                       |      |      |      |
| VISCOSITY, PARTICLE   |                       |      |      |      |
| SIZE, PERCENT SOLIDS, |                       |      |      |      |
| AND EQUIPMENT FACTORS |                       |      |      |      |
| SUCH AS FILLING       |                       |      |      |      |
| METHOD, HEAD SPACING  |                       |      |      |      |
| AND ROTATIONAL        |                       |      |      |      |
| SPEED---SEE PP. 8,9&  |                       |      |      |      |
| 22 OF LACF FIELD      |                       |      |      |      |
| GUIDE- PART 2. A      |                       |      |      |      |
| CHANGE IN ANY OF      |                       |      |      |      |
| THESE FACTORS COULD   |                       |      |      |      |
| RESULT IN AN UNDER    |                       |      |      |      |
| PROCESS.)             |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 8\. IF PROCESS        |                       |      |      |      |
| CHANGE(S) HAVE BEEN   |                       |      |      |      |
| MADE THAT COULD       |                       |      |      |      |
| AFFECT THE ATTAINMENT |                       |      |      |      |
| OF COMMERCIAL         |                       |      |      |      |
| STERILITY, HAVE THE   |                       |      |      |      |
| CHANGE(S) BEEN        |                       |      |      |      |
| REVIEWED AND          |                       |      |      |      |
| SUBSTANTIATED BY A    |                       |      |      |      |
| QUALIFIED SCIENTIFIC  |                       |      |      |      |
| AUTHORITY AND FILED   |                       |      |      |      |
| WITH FDA?             |                       |      |      |      |
| (108.35(c)(2)(ii))    |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 9.  THE FOLLOWING     |                       |      |      |      |
|     PRODUCTS WERE     |                       |      |      |      |
|     COVERED DURING    |                       |      |      |      |
|     THIS INSPECTION:  |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| > ***PRODUCT***       | ***STYLE OF PACK***   | ***C |      |      |
| >                     |                       | ONTA |      |      |
| >                     |                       | INER |      |      |
|                       |                       | TYPE |      |      |
|                       |                       | /SIZ |      |      |
|                       |                       | E*** |      |      |
|                       |                       |      |      |      |
|                       |                       |      |      |      |
|                       |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 10. LIST ALL CRITICAL |                       |      |      |      |
|     FACTORS TO THE    |                       |      |      |      |
|     ATTAINMENT OF     |                       |      |      |      |
|     COMMERCIAL        |                       |      |      |      |
|     STERILITY PER     |                       |      |      |      |
|     PROCESS AUTHORITY |                       |      |      |      |
|     LETTER AND FILING |                       |      |      |      |
|     FORM(S) FOR       |                       |      |      |      |
|     PRODUCTS COVERED  |                       |      |      |      |
|     DURING THIS       |                       |      |      |      |
|     INSPECTION:       |                       |      |      |      |
|                       |                       |      |      |      |
| *(INCLUDE VENT        |                       |      |      |      |
| TIME/TEMP., INITIAL   |                       |      |      |      |
| TEMPERATURE, MIN.     |                       |      |      |      |
| PROCESS TIME/TEMP.    |                       |      |      |      |
| AND ALL OTHER         |                       |      |      |      |
| CRITICAL FACTOR       |                       |      |      |      |
| TARGET VALUES---LIST  |                       |      |      |      |
| OTHER CRITICAL        |                       |      |      |      |
| FACTORS AND OPERATING |                       |      |      |      |
| PROCESSES IN          |                       |      |      |      |
| COMMENTS.)*           |                       |      |      |      |
|                       |                       |      |      |      |
| RETORT VENT SCHEDULE: |                       |      |      |      |
| [    ]{.underline}    |                       |      |      |      |
| MINUTES AND TO        |                       |      |      |      |
| [     ]{.underline}   |                       |      |      |      |
| °F.                   |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
|                       |                       | ***  |      |      |
|                       |                       | MIN. |      |      |
|                       |                       | CRIT |      |      |
|                       |                       | ICAL |      |      |
|                       |                       | FA   |      |      |
|                       |                       | CTOR |      |      |
|                       |                       | S*** |      |      |
+-----------------------+-----------------------+------+------+------+
|                       |                       | *    | *    | *    |
|                       |                       | Init | Proc | Proc |
|                       |                       | ial* | ess* | ess* |
|                       |                       |      |      |      |
|                       |                       | *Te  | *T   | *Te  |
|                       |                       | mp.* | ime* | mp.* |
+-----------------------+-----------------------+------+------+------+
| > ***PRODUCT***       | ***CONTAINER          |      |      |      |
| >                     | TYPE/SIZE***          |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
|                       |                       |      |      |      |
|                       |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| COMMENTS, INCLUDING   |                       |      |      |      |
| OTHER CRITICAL        |                       |      |      |      |
| FACTORS:              |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **RAW MATERIALS --    |                       |      |      |      |
| 113.81**              |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 11\. DOES THE FIRM    |                       |      |      |      |
| TAKE ADEQUATE         |                       |      |      |      |
| MEASURES TO PREVENT   |                       |      |      |      |
| THE BUILD-UP OF       |                       |      |      |      |
| MICROORGANISMS IN     |                       |      |      |      |
| UNPROCESSED PRODUCT   |                       |      |      |      |
| BEFORE THERMAL        |                       |      |      |      |
| PROCESSING? Yes No    |                       |      |      |      |
|                       |                       |      |      |      |
| *FOR EXAMPLE, RAW     |                       |      |      |      |
| VEGETABLES SHOULD BE  |                       |      |      |      |
| ADEQUATELY CLEANED    |                       |      |      |      |
| BEFORE FILLING.       |                       |      |      |      |
| FILLED/SEAMED AND\    |                       |      |      |      |
| UNPROCESSED CANS      |                       |      |      |      |
| SHOULD BE RETORTED    |                       |      |      |      |
| WITHIN A REASONABLE   |                       |      |      |      |
| TIME LIMIT TO PREVENT |                       |      |      |      |
| INCIPIENT SPOILAGE.\  |                       |      |      |      |
| HOT WATER BLANCHERS   |                       |      |      |      |
| SHOULD BE MAINTAINED  |                       |      |      |      |
| AT TEMPERATURES ABOVE |                       |      |      |      |
| THAT WHICH WILL       |                       |      |      |      |
| SUPPORT THE GROWTH\   |                       |      |      |      |
| OF THERMOPHILES AND   |                       |      |      |      |
| BE EMPTIED, CLEANED   |                       |      |      |      |
| AND SANITIZED ON A    |                       |      |      |      |
| REGULAR BASIS TO      |                       |      |      |      |
| PREVENT THE GROWTH    |                       |      |      |      |
| OF*                   |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| *THERMOPHILES. RAW    |                       |      |      |      |
| MATERIALS SUSCEPTIBLE |                       |      |      |      |
| TO CONTAMINATION BY   |                       |      |      |      |
| THERMOPHILES (SUGAR,  |                       |      |      |      |
| SALT, ETC.) SHOULD BE |                       |      |      |      |
| RECEIVED WITH A       |                       |      |      |      |
| SUPPLIER'S GUARANTEE  |                       |      |      |      |
| OR CERTIFICATE OF     |                       |      |      |      |
| ANALYSIS)*            |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 9.  WHAT IS THE       |                       |      |      |      |
|     SOURCE OF WATER   |                       |      |      |      |
|     USED FOR          |                       |      |      |      |
|     PROCESSING AND    |                       |      |      |      |
|     CLEAN-UP IN THE   |                       |      |      |      |
|     PLANT?            |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 13\. IS THE PLANT     |                       |      |      |      |
| WATER ADEQUATELY      |                       |      |      |      |
| TREATED WITH CHLORINE |                       |      |      |      |
| OR OTHER APPROVED     |                       |      |      |      |
| CHEMICALS TO RENDER   |                       |      |      |      |
| IT POTABLE? Yes No    |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 14\. ARE ALL FOOD AND |                       |      |      |      |
| COLOR ADDITIVES FDA   |                       |      |      |      |
| APPROVED? Yes No N/A  |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 15\. ARE ADDITIVES    |                       |      |      |      |
| USED TO TREAT BOILER  |                       |      |      |      |
| WATER AND ARE THEY    |                       |      |      |      |
| APPROVED FOR SUCH     |                       |      |      |      |
| USE? (LIST ADDITIVES  |                       |      |      |      |
| THAT ARE USED         |                       |      |      |      |
| INCLUDING CHEMICAL    |                       |      |      |      |
| NAME) Yes No          |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **PRODUCT PREPARATION |                       |      |      |      |
| -- 113.81**           |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 16. ARE PRODUCTS      |                       |      |      |      |
|     PREPARED          |                       |      |      |      |
|     ACCORDING TO THE  |                       |      |      |      |
|     METHOD            |                       |      |      |      |
|     (HYDRATING,       |                       |      |      |      |
|     DRYING,           |                       |      |      |      |
|     ACIDIFYING,       |                       |      |      |      |
|     BLANCHING, ETC.)? |                       |      |      |      |
|     AND/OR            |                       |      |      |      |
|     FORMULATION       |                       |      |      |      |
|     SPECIFIED IN THE  |                       |      |      |      |
|     RECOMMENDED       |                       |      |      |      |
|     SCHEDULED         |                       |      |      |      |
|     PROCESS?          |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No N/A            |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 17\. WHEN MAINTENANCE |                       |      |      |      |
| OF pH (ABOVE 4.6) OF  |                       |      |      |      |
| A NORMALLY LOW-ACID   |                       |      |      |      |
| FOOD IS A BASIS FOR A |                       |      |      |      |
| SCHEDULED PROCESS,    |                       |      |      |      |
| DOES THE FIRM ENSURE  |                       |      |      |      |
| THAT THE EQUILIBRIUM  |                       |      |      |      |
| pH OF THE FINISHED    |                       |      |      |      |
| PRODUCT MEETS THE\    |                       |      |      |      |
| VALUE SPECIFIED IN    |                       |      |      |      |
| THE SCHEDULED         |                       |      |      |      |
| PROCESS? -- 113.81(e) |                       |      |      |      |
| Yes No N/A            |                       |      |      |      |
|                       |                       |      |      |      |
| *IN THIS CASE, THE    |                       |      |      |      |
| FIRM MUST MONITOR pH  |                       |      |      |      |
| AS A CRITICAL FACTOR  |                       |      |      |      |
| AT INTERVALS OF       |                       |      |      |      |
| SUFFICIENT FREQUENCY  |                       |      |      |      |
| AND PREPARE/MAINTAIN  |                       |      |      |      |
| RECORDS; THE pH METER |                       |      |      |      |
| SHOULD BE CALIBRATED  |                       |      |      |      |
| TO ENSURE IT'S        |                       |      |      |      |
| ACCURACY.*            |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 16. FOR WATER         |                       |      |      |      |
|     ACTIVITY          |                       |      |      |      |
|     CONTROLLED        |                       |      |      |      |
|     PROCESSES, IS THE |                       |      |      |      |
|     WATER ACTIVITY    |                       |      |      |      |
|     (Aw) CAREFULLY    |                       |      |      |      |
|     CONTROLLED TO     |                       |      |      |      |
|     ENSURE THAT THE   |                       |      |      |      |
|     Aw OF THE         |                       |      |      |      |
|     FINISHED PRODUCT  |                       |      |      |      |
|     MEETS THAT OF THE |                       |      |      |      |
|     SCHEDULED         |                       |      |      |      |
|     PROCESS? --       |                       |      |      |      |
|     113.81(f)         |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No N/A            |                       |      |      |      |
|                       |                       |      |      |      |
| *(WHEN NORMALLY       |                       |      |      |      |
| LOW-ACID FOODS        |                       |      |      |      |
| REQUIRE SUFFICIENT    |                       |      |      |      |
| SOLUTE TO PERMIT SAFE |                       |      |      |      |
| PROCESSING AT LOW\    |                       |      |      |      |
| TEMPERATURES, SUCH AS |                       |      |      |      |
| IN BOILING WATER,     |                       |      |      |      |
| THERE SHALL BE        |                       |      |      |      |
| CAREFUL SUPERVISION   |                       |      |      |      |
| TO ENSURE THAT THE\   |                       |      |      |      |
| EQUILIBRIUM WATER     |                       |      |      |      |
| ACTIVITY OF THE       |                       |      |      |      |
| FINISHED PRODUCT      |                       |      |      |      |
| MEETS THAT OF THE     |                       |      |      |      |
| SCHEDULED PROCESS     |                       |      |      |      |
| 113.81(F)). IN THIS   |                       |      |      |      |
| CASE, THE FIRM MUST   |                       |      |      |      |
| MONITOR WATER         |                       |      |      |      |
| ACTIVITY AT INTERVALS |                       |      |      |      |
| OF SUFFICIENT         |                       |      |      |      |
| FREQUENCY AND         |                       |      |      |      |
| PREPARE/MAINTAIN      |                       |      |      |      |
| RECORDS; THE WATER    |                       |      |      |      |
| ACTIVITY METER SHOULD |                       |      |      |      |
| BE CALIBRATED TO      |                       |      |      |      |
| ENSURE ITS ACCURACY.* |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 19\. ARE INGREDIENTS  |                       |      |      |      |
| WEIGHED PROPERLY      |                       |      |      |      |
| USING ACCURATE        |                       |      |      |      |
| SCALES? Yes No        |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **EMPTY CONTAINER     |                       |      |      |      |
| INTEGRITY**           |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 20\. DESCRIBE THE     |                       |      |      |      |
| CONTAINERS BEING USED |                       |      |      |      |
| DURING THIS           |                       |      |      |      |
| INSPECTION (SIZE,     |                       |      |      |      |
| MATERIAL COMPOSITION, |                       |      |      |      |
| ETC.):                |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 21. SOURCE FOR THE    |                       |      |      |      |
|     FIRM'S            |                       |      |      |      |
|     CONTAINERS:       |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
| INTEGRITY TESTS       |                       |      |      |      |
| PERFORMED BY THE FIRM |                       |      |      |      |
| OR THE SUPPLIER ON    |                       |      |      |      |
| INCOMING CONTAINERS:  |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
| DESCRIBE HOW THE FIRM |                       |      |      |      |
| ASSURES THAT INCOMING |                       |      |      |      |
| CONTAINERS MEET THE   |                       |      |      |      |
| SUPPLIER'S            |                       |      |      |      |
| SPECIFICATION\        |                       |      |      |      |
| (FOR EXAMPLE, DO      |                       |      |      |      |
| INCOMING CANS HAVE    |                       |      |      |      |
| THE PROPER BASE       |                       |      |      |      |
| WEIGHT, ENAMEL        |                       |      |      |      |
| COATING, SEAMING      |                       |      |      |      |
| COMPOUND, ETC?):      |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 22. DOES THE FIRM     |                       |      |      |      |
|     HAVE WRITTEN      |                       |      |      |      |
|     CRITERIA TO       |                       |      |      |      |
|     ACCEPT OR REJECT  |                       |      |      |      |
|     INCOMING EMPTY    |                       |      |      |      |
|     CONTAINER STOCK?  |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| ARE RECORDS KEPT OF   |                       |      |      |      |
| ACCEPTED/REJECTED     |                       |      |      |      |
| CONTAINER STOCK? Yes  |                       |      |      |      |
| No                    |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 23\. DOES THE FIRM    |                       |      |      |      |
| CORRELATE INCOMING    |                       |      |      |      |
| CONTAINERS (NAME OF   |                       |      |      |      |
| SUPPLIER, CODES, ETC) |                       |      |      |      |
| WITH CONTAINER USAGE  |                       |      |      |      |
| IN PRODUCTION? Yes No |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 24\. ARE EMPTY        |                       |      |      |      |
| CONTAINER HANDLING    |                       |      |      |      |
| PROCEDURES ADEQUATE   |                       |      |      |      |
| TO PREVENT DAMAGE?    |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 25\. ARE CONTAINERS   |                       |      |      |      |
| AND LIDS CLEAN BEFORE |                       |      |      |      |
| FILLING? Yes No       |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **FILLING**           |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 26\. DESCRIBE THE     |                       |      |      |      |
| METHOD OF FILLING     |                       |      |      |      |
| CONTAINERS (HAND,     |                       |      |      |      |
| VIBRATION, POCKET,    |                       |      |      |      |
| ETC.) IS THIS METHOD  |                       |      |      |      |
| THE SAME AS USED      |                       |      |      |      |
| DURING PROCESS        |                       |      |      |      |
| ESTABLISHMENT TESTS?  |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 27. WERE ALL CRITICAL |                       |      |      |      |
|     FACTORS (FILL WT, |                       |      |      |      |
|     HEAD SPACE, ETC)  |                       |      |      |      |
|     BEING ADEQUATELY  |                       |      |      |      |
|     CONTROLLED?       |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| *(CRITICAL FACTORS    |                       |      |      |      |
| SPECIFIED IN THE      |                       |      |      |      |
| SCHEDULED PROCESS     |                       |      |      |      |
| SHALL BE MEASURED AND |                       |      |      |      |
| RECORDED ON THE       |                       |      |      |      |
| PROCESSING RECORD AT  |                       |      |      |      |
| INTERVALS OF          |                       |      |      |      |
| SUFFICIENT FREQUENCY  |                       |      |      |      |
| TO ENSURE THAT THE    |                       |      |      |      |
| FACTORS ARE WITHIN    |                       |      |      |      |
| THE LIMITS SPECIFIED  |                       |      |      |      |
| IN THE SCHEDULED      |                       |      |      |      |
| PROCESS               |                       |      |      |      |
| 113.40(A)(14)) THERE  |                       |      |      |      |
| ARE NUMEROUS CRITICAL |                       |      |      |      |
| FACTORS TO CONTROL    |                       |      |      |      |
| DEPENDING ON THE      |                       |      |      |      |
| PRODUCT, CONTAINER    |                       |      |      |      |
| AND PROCESSING        |                       |      |      |      |
| SYSTEM, ETC.          |                       |      |      |      |
| -113.81(C) (SEE LACF  |                       |      |      |      |
| INSPECTION GUIDE-PART |                       |      |      |      |
| 2).*                  |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 28\. DOES PRODUCT     |                       |      |      |      |
| OVERLAY THE EDGES OF  |                       |      |      |      |
| FILLED CONTAINERS?    |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 29\. ARE CAN FLANGES  |                       |      |      |      |
| FREE OF DAMAGE AFTER  |                       |      |      |      |
| FILLING? Yes No       |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **CLOSING**           |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 30. LIST THE          |                       |      |      |      |
|     MANUFACTURER,     |                       |      |      |      |
|     MODEL NO. AND     |                       |      |      |      |
|     TYPE OF CLOSING   |                       |      |      |      |
|     MACHINES IN USE   |                       |      |      |      |
|     BY THE FIRM:      |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 31. IS CONTAINER      |                       |      |      |      |
|     CLOSURE EQUIPMENT |                       |      |      |      |
|     MAINTAINED        |                       |      |      |      |
|     SANITARY AND IN A |                       |      |      |      |
|     GOOD STATE OF     |                       |      |      |      |
|     REPAIR?           |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| *(FOR EXAMPLE, CHECK  |                       |      |      |      |
| TO SEE IF THE FIRM    |                       |      |      |      |
| HAS A MAINTENANCE LOG |                       |      |      |      |
| FOR THE DOUBLE        |                       |      |      |      |
| SEAMERS THAT          |                       |      |      |      |
| DOCUMENTS ROUTINE     |                       |      |      |      |
| MAINTENANCE SUCH AS   |                       |      |      |      |
| ADJUSTING OR CHANGING |                       |      |      |      |
| CHUCKS & ROLLS, ETC.; |                       |      |      |      |
| VISUAL OBSERVATION OF |                       |      |      |      |
| THE\                  |                       |      |      |      |
| SEAMER LOG AND REVIEW |                       |      |      |      |
| OF SANITATION         |                       |      |      |      |
| MONITORING RECORDS    |                       |      |      |      |
| CAN INDICATE HOW THE  |                       |      |      |      |
| FIRM CLEANS AND       |                       |      |      |      |
| MAINTAINS THEIR       |                       |      |      |      |
| DOUBLE SEAMING        |                       |      |      |      |
| EQUIPMENT)*           |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 32\. DURING           |                       |      |      |      |
| PRODUCTION RUNS, DOES |                       |      |      |      |
| THE FIRM PERFORM      |                       |      |      |      |
| VISUAL AND            |                       |      |      |      |
| DESTRUCTIVE TESTS ON  |                       |      |      |      |
| CONTAINER SEAMS/      |                       |      |      |      |
| SEALS IN ACCORDANCE   |                       |      |      |      |
| WITH PART 113.60(A)?  |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| *DESCRIBE ALL VISUAL  |                       |      |      |      |
| AND DESTRUCTIVE TESTS |                       |      |      |      |
| PERFORMED INCLUDING   |                       |      |      |      |
| TESTING FREQUENCY AND |                       |      |      |      |
| ALL MEASURED          |                       |      |      |      |
| PARAMETERS (SEE LACF  |                       |      |      |      |
| FIELD GUIDE-PART 3    |                       |      |      |      |
| FOR A DESCRIPTION OF  |                       |      |      |      |
| METAL, GLASS AND      |                       |      |      |      |
| FLEXIBLE PACKAGE      |                       |      |      |      |
| CLOSURES, SEALING     |                       |      |      |      |
| PARAMETERS, CONTAINER |                       |      |      |      |
| DEFECTS AND INTEGRITY |                       |      |      |      |
| TESTS)*               |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 33. ARE FILLED/SEALED |                       |      |      |      |
|     CONTAINERS        |                       |      |      |      |
|     ADEQUATELY        |                       |      |      |      |
|     HANDLED IN A      |                       |      |      |      |
|     MANNER THAT       |                       |      |      |      |
|     REDUCES THE       |                       |      |      |      |
|     POTENTIAL FOR     |                       |      |      |      |
|     LEAKS AND ASSURES |                       |      |      |      |
|     GOOD INTEGRITY?   |                       |      |      |      |
|     Yes No            |                       |      |      |      |
|                       |                       |      |      |      |
| *(FOR EXAMPLE, RETORT |                       |      |      |      |
| CRATES SHOULD NOT     |                       |      |      |      |
| HAVE SHARP OR POINTED |                       |      |      |      |
| SURFACES THAT COULD   |                       |      |      |      |
| PUNCTURE\             |                       |      |      |      |
| CONTAINERS;           |                       |      |      |      |
| CONTAINERS SHOULD BE  |                       |      |      |      |
| LOADED INTO CRATES    |                       |      |      |      |
| AND RETORTS AND       |                       |      |      |      |
| UNLOADED WITHOUT      |                       |      |      |      |
| CAUSING CONTAINER     |                       |      |      |      |
| DAMAGE)*              |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 34\. DO PRODUCT CODES |                       |      |      |      |
| COMPLY WITH PART      |                       |      |      |      |
| 113.60(C)? Yes No     |                       |      |      |      |
|                       |                       |      |      |      |
| *(THE CODE SHALL BE   |                       |      |      |      |
| PERMANENTLY VISIBLE   |                       |      |      |      |
| TO THE NAKED EYE AND  |                       |      |      |      |
| SHALL IDENTIFY THE    |                       |      |      |      |
| PACKER, PRODUCT,      |                       |      |      |      |
| YEAR, DAY AND PERIOD  |                       |      |      |      |
| OF PACK)*             |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
| DESCRIBE THE CODING   |                       |      |      |      |
| SYSTEM INCLUDING A    |                       |      |      |      |
| CODE BREAKDOWN FOR    |                       |      |      |      |
| PRODUCTS PRODUCED     |                       |      |      |      |
| DURING THIS           |                       |      |      |      |
| INSPECTION:           |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **THERMAL PROCESSING  |                       |      |      |      |
| EQUIPMENT &           |                       |      |      |      |
| PROCEDURES --         |                       |      |      |      |
| 113.40**              |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 35\. WHAT TYPE OF     |                       |      |      |      |
| THERMAL PROCESSING    |                       |      |      |      |
| EQUIPMENT DOES THE    |                       |      |      |      |
| FIRM USE? (LIST THE   |                       |      |      |      |
| NUMBER AND TYPE OF    |                       |      |      |      |
| RETORTS; SPECIFY      |                       |      |      |      |
| WHICH RETORTS WERE    |                       |      |      |      |
| BEING USED DURING     |                       |      |      |      |
| THIS INSPECTION)      |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 36\. DOES THE THERMAL |                       |      |      |      |
| PROCESSING EQUIPMENT  |                       |      |      |      |
| COMPLY WITH PART      |                       |      |      |      |
| 113.40? Yes No        |                       |      |      |      |
|                       |                       |      |      |      |
| *(FOR A DETAILED      |                       |      |      |      |
| DESCRIPTION OF        |                       |      |      |      |
| DIFFERENT THERMAL     |                       |      |      |      |
| PROCESSING EQUIPMENT  |                       |      |      |      |
| AND SYSTEMS AND THE   |                       |      |      |      |
| REGULATION            |                       |      |      |      |
| REQUIREMENTS, SEE PP. |                       |      |      |      |
| 23-40 OF LACF FIELD   |                       |      |      |      |
| GUIDE-PART 2 AND      |                       |      |      |      |
| 21CFR PART 113.40;    |                       |      |      |      |
| REFER TO ATTACHMENTS  |                       |      |      |      |
| A-I FOR REPORTING     |                       |      |      |      |
| FORMATS COVERING THE  |                       |      |      |      |
| DIFFERENT THERMAL     |                       |      |      |      |
| PROCESSING SYSTEMS)*  |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 37\. WHERE VENTING    |                       |      |      |      |
| ARRANGEMENTS VARY     |                       |      |      |      |
| FROM THE EXAMPLES IN  |                       |      |      |      |
| 113.40(a)(12), HAVE   |                       |      |      |      |
| TEMPERATURE           |                       |      |      |      |
| DISTRIBUTION STUDIES  |                       |      |      |      |
| BEEN CONDUCTED ON THE |                       |      |      |      |
| RETORTS TO ESTABLISH  |                       |      |      |      |
| EQUAL TEMPERATURE     |                       |      |      |      |
| DISTRIBUTION AND,     |                       |      |      |      |
| WHERE APPLICABLE, A   |                       |      |      |      |
| VENT CYCLE? Yes No    |                       |      |      |      |
|                       |                       |      |      |      |
| IF SO, WHO CONDUCTED  |                       |      |      |      |
| THE STUDY, WHEN WAS   |                       |      |      |      |
| IT CONDUCTED AND IS   |                       |      |      |      |
| THERE DOCUMENTATION   |                       |      |      |      |
| AVAILABLE THAT        |                       |      |      |      |
| DOCUMENTS THE STUDY?  |                       |      |      |      |
|                       |                       |      |      |      |
| *(FOR AN EXPLANATION  |                       |      |      |      |
| OF TEMPERATURE        |                       |      |      |      |
| DISTRIBUTION, SEE P.  |                       |      |      |      |
| 21 OF LACF FIELD      |                       |      |      |      |
| GUIDE -- PART 2)*     |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
| OTHER COMMENTS:       |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 38\. HAVE THERE BEEN  |                       |      |      |      |
| ANY CHANGES TO THE    |                       |      |      |      |
| RETORTS OR THERMAL    |                       |      |      |      |
| PROCESSING SYSTEM     |                       |      |      |      |
| SINCE THE LAST        |                       |      |      |      |
| TEMPERATURE           |                       |      |      |      |
| DISTRIBUTION STUDY    |                       |      |      |      |
| THAT COULD AFFECT     |                       |      |      |      |
| TEMPERATURE           |                       |      |      |      |
| DISTRIBUTION?         |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| *(THE RETORT DESIGN,  |                       |      |      |      |
| LOADING               |                       |      |      |      |
| CONFIGURATION,        |                       |      |      |      |
| SMALLEST CONTAINER    |                       |      |      |      |
| SIZE AND MANY OTHER   |                       |      |      |      |
| FACTORS CAN AFFECT\   |                       |      |      |      |
| THE ATTAINMENT OF     |                       |      |      |      |
| TEMPERATURE           |                       |      |      |      |
| DISTRIBUTION IN THE   |                       |      |      |      |
| RETORT -- SEE PP      |                       |      |      |      |
| 21-22 OF LACF FIELD   |                       |      |      |      |
| GUIDE-PART 2. A\      |                       |      |      |      |
| CHANGE IN ANY OF      |                       |      |      |      |
| THESE FACTORS COULD   |                       |      |      |      |
| NECESSITATE A NEW     |                       |      |      |      |
| TEMPERATURE           |                       |      |      |      |
| DISTRIBUTION STUDY    |                       |      |      |      |
| AND POSSIBLY\         |                       |      |      |      |
| A NEW VENT SCHEDULE.  |                       |      |      |      |
| IF A CHANGE HAS BEEN  |                       |      |      |      |
| MADE IN THE THERMAL   |                       |      |      |      |
| PROCESSING SYSTEM     |                       |      |      |      |
| THAT COULD AFFECT     |                       |      |      |      |
| TEMPERATURE           |                       |      |      |      |
| DISTRIBUTION, THE     |                       |      |      |      |
| FIRM SHOULD HAVE ON   |                       |      |      |      |
| FILE DOCUMENTATION OF |                       |      |      |      |
| THE CHANGE, INCLUDING |                       |      |      |      |
| THE\                  |                       |      |      |      |
| REVIEW AND APPROVAL   |                       |      |      |      |
| BY A QUALIFIED        |                       |      |      |      |
| PROCESS AUTHORITY.)*  |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 39\. DOES THE FIRM    |                       |      |      |      |
| OPERATE THE RETORTS   |                       |      |      |      |
| USING THE PROCEDURE   |                       |      |      |      |
| DEVELOPED DURING THE  |                       |      |      |      |
| TEMPERATURE           |                       |      |      |      |
| DISTRIBUTRION STUDY   |                       |      |      |      |
| OR AS OUTLINED IN     |                       |      |      |      |
| OTHER SUPPORTING      |                       |      |      |      |
| DOCUMENTATION? Yes No |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 40\. DO CRATES,       |                       |      |      |      |
| TRAYS, GONDOLAS, ETC  |                       |      |      |      |
| FOR HOLDING           |                       |      |      |      |
| CONTAINERS FOR        |                       |      |      |      |
| PROCESSING IN STEAM   |                       |      |      |      |
| IN STILL RETORTS MEET |                       |      |      |      |
| THE REQUIREMENTS OF   |                       |      |      |      |
| 113.40(a)(9)? Yes No  |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **THERMAL PROCESSING  |                       |      |      |      |
| ROOM OPERATIONS --    |                       |      |      |      |
| 113.87**              |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 41\. ARE SCHEDULED    |                       |      |      |      |
| PROCESSES AND VENTING |                       |      |      |      |
| PROCEDURES (IF        |                       |      |      |      |
| APPLICABLE) POSTED IN |                       |      |      |      |
| THE RETORT ROOM OR    |                       |      |      |      |
| READILY AVAILABLE TO  |                       |      |      |      |
| THE RETORT OPERATOR?  |                       |      |      |      |
| -- 113.87(a) Yes No   |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 42\. DO POSTED        |                       |      |      |      |
| (OPERATING) SCHEDULED |                       |      |      |      |
| PROCESSES MEET OR     |                       |      |      |      |
| EXCEED THE            |                       |      |      |      |
| RECOMMENDATIONS OF    |                       |      |      |      |
| THE PROCESS AUTHORITY |                       |      |      |      |
| AND PROCESS SCHEDULES |                       |      |      |      |
| FILED WITH FDA? Yes   |                       |      |      |      |
| No                    |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 43\. HAS THE FIRM     |                       |      |      |      |
| ESTABLISHED AN        |                       |      |      |      |
| ADEQUATE SYSTEM FOR   |                       |      |      |      |
| PRODUCT TRAFFIC       |                       |      |      |      |
| CONTROL IN THE RETORT |                       |      |      |      |
| ROOM TO PREVENT       |                       |      |      |      |
| UNRETORTED PRODUCT    |                       |      |      |      |
| FROM BYPASSING THE    |                       |      |      |      |
| RETORT PROCESS? Yes   |                       |      |      |      |
| No                    |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| *(EACH RETORT BASKET  |                       |      |      |      |
| OR ONE OR MORE CANS   |                       |      |      |      |
| WITHIN SHALL BE       |                       |      |      |      |
| PLAINLY MARKED WITH   |                       |      |      |      |
| HEAT-SENSITIVE        |                       |      |      |      |
| INDICATOR\            |                       |      |      |      |
| TAPE, DYE OR PAINT OR |                       |      |      |      |
| BY OTHER EFFECTIVE    |                       |      |      |      |
| MEANS THAT WILL       |                       |      |      |      |
| INDICATE VISUALLY TO  |                       |      |      |      |
| THERMAL PROCESSING\   |                       |      |      |      |
| PERSONNEL THOSE UNITS |                       |      |      |      |
| THAT HAVE BEEN        |                       |      |      |      |
| RETORTED; A VISUAL    |                       |      |      |      |
| CHECK SHALL BE        |                       |      |      |      |
| PERFORMED TO          |                       |      |      |      |
| DETERMINE\            |                       |      |      |      |
| WHETHER OR NOT THE    |                       |      |      |      |
| APPROPRIATE CHANGE    |                       |      |      |      |
| HAS OCCURRED IN THE   |                       |      |      |      |
| HEAT-SENSITIVE        |                       |      |      |      |
| INDICATOR AS A RESULT |                       |      |      |      |
| OF\                   |                       |      |      |      |
| RETORTING FOR ALL     |                       |      |      |      |
| RETORT BASKETS TO     |                       |      |      |      |
| ENSURE THAT EACH UNIT |                       |      |      |      |
| OF PRODUCT HAS BEEN   |                       |      |      |      |
| RETORTED; A WRITTEN\  |                       |      |      |      |
| RECORD OF THESE       |                       |      |      |      |
| CHECKS SHOULD BE MADE |                       |      |      |      |
| -- 113.87(b)).*       |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 44\. IS THE INITIAL   |                       |      |      |      |
| TEMPERATURE,"IT", OF  |                       |      |      |      |
| THE CONTENTS OF       |                       |      |      |      |
| CONTAINERS TO BE      |                       |      |      |      |
| PROCESSED DETERMINED  |                       |      |      |      |
| AND RECORDED WITH     |                       |      |      |      |
| SUFFICIENT FREQUENCY? |                       |      |      |      |
| -- 113.87(c) Yes No   |                       |      |      |      |
|                       |                       |      |      |      |
| *MEASURE THE "IT" OF  |                       |      |      |      |
| AT LEAST 1 RETORT     |                       |      |      |      |
| LOAD WITH A           |                       |      |      |      |
| CALIBRATED            |                       |      |      |      |
| THERMOMETER AND       |                       |      |      |      |
| REPORT THE RESULTS IN |                       |      |      |      |
| "COMMENTS".*          |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
| *(THE INITIAL         |                       |      |      |      |
| TEMPERATURE IS A      |                       |      |      |      |
| CRITICAL FACTOR IN    |                       |      |      |      |
| THE ATTAINMENT OF     |                       |      |      |      |
| COMMERCIAL            |                       |      |      |      |
| STERILITY---EQUALLY   |                       |      |      |      |
| IMPORTANT AS PROCESS  |                       |      |      |      |
| TIME, RETORT          |                       |      |      |      |
| TEMPERATURE AND ANY   |                       |      |      |      |
| OTHER CRITICAL        |                       |      |      |      |
| FACTOR)*              |                       |      |      |      |
|                       |                       |      |      |      |
| DOES THE "IT"         |                       |      |      |      |
| MEASURED BY THE       |                       |      |      |      |
| INVESTIGATOR AGREE    |                       |      |      |      |
| WITH THE FIRM'S       |                       |      |      |      |
| MEASURED "IT" AND     |                       |      |      |      |
| DOES THIS "IT" AT     |                       |      |      |      |
| LEAST MEET OR EXCEED  |                       |      |      |      |
| THE MINIMUM "IT"      |                       |      |      |      |
| FILED WITH FDA? Yes   |                       |      |      |      |
| No                    |                       |      |      |      |
|                       |                       |      |      |      |
| IF NO, EXPLAIN:       |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 45\. ARE PROCEDURES   |                       |      |      |      |
| FOR MEASURING INITIAL |                       |      |      |      |
| TEMPERATURE PROPERLY  |                       |      |      |      |
| MADE? Yes No          |                       |      |      |      |
|                       |                       |      |      |      |
| *(INITIAL TEMPERATURE |                       |      |      |      |
| IS DETERMINED BY      |                       |      |      |      |
| SELECTING A CONTAINER |                       |      |      |      |
| REPRESENTING THE      |                       |      |      |      |
| COLDEST CONTAINER IN  |                       |      |      |      |
| THE RETORT LOAD; JUST |                       |      |      |      |
| PRIOR TO THE START OF |                       |      |      |      |
| THE PROCESS, THE      |                       |      |      |      |
| CONTENTS OF THE       |                       |      |      |      |
| CONTAINER ARE         |                       |      |      |      |
| THOROUGHLY\           |                       |      |      |      |
| MIXED AND THE         |                       |      |      |      |
| TEMPERATURE IS        |                       |      |      |      |
| DETERMINED USING A    |                       |      |      |      |
| CALIBRATED            |                       |      |      |      |
| THERMOMETER. FOR      |                       |      |      |      |
| THOSE RETORT SYSTEMS\ |                       |      |      |      |
| THAT USE WATER PRIOR  |                       |      |      |      |
| TO OR DURING          |                       |      |      |      |
| PROCESSING,           |                       |      |      |      |
| PROVISIONS SHALL BE   |                       |      |      |      |
| MADE TO ENSURE THAT   |                       |      |      |      |
| THE INITIAL           |                       |      |      |      |
| TEMPERATURE IS        |                       |      |      |      |
| REPRESENTATIVE OF     |                       |      |      |      |
| EITHER THE COLDEST    |                       |      |      |      |
| CONTAINER (COLDEST    |                       |      |      |      |
| COMPONENT IN          |                       |      |      |      |
| CONTAINER) OR THE     |                       |      |      |      |
| WATER IN THE RETORT,  |                       |      |      |      |
| WHICHEVER IS COLDER)  |                       |      |      |      |
| -- 113.87(c)*         |                       |      |      |      |
|                       |                       |      |      |      |
| IF QUESTIONABLE,      |                       |      |      |      |
| DESCRIBE THE FIRM'S   |                       |      |      |      |
| PROCEDURE AND         |                       |      |      |      |
| FREQUENCY FOR         |                       |      |      |      |
| CHECKING PRODUCT      |                       |      |      |      |
| "IT":                 |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 46\. ARE THERMAL      |                       |      |      |      |
| PROCESS TIMING        |                       |      |      |      |
| DEVICES ACCURATE? Yes |                       |      |      |      |
| No                    |                       |      |      |      |
|                       |                       |      |      |      |
| *(POCKET OR           |                       |      |      |      |
| WRISTWATCHES ARE NOT  |                       |      |      |      |
| CONSIDERED            |                       |      |      |      |
| SATISFACTORY; DIGITAL |                       |      |      |      |
| CLOCKS THAT DO NOT    |                       |      |      |      |
| DISPLAY SECONDS MAY   |                       |      |      |      |
| BE USED IF THE        |                       |      |      |      |
| OPERATING PROCESS AND |                       |      |      |      |
| THE VENTING SCHEDULE  |                       |      |      |      |
| HAVE A 1-MINUTE OR    |                       |      |      |      |
| GREATER SAFETY FACTOR |                       |      |      |      |
| OVER THE SCHEDULED    |                       |      |      |      |
| PROCESS) --           |                       |      |      |      |
| 113.87(d).*           |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 47\. DOES THE RETORT  |                       |      |      |      |
| OPERATOR ADEQUATELY   |                       |      |      |      |
| CONTROL AND MONITOR   |                       |      |      |      |
| THE RETORT DURING     |                       |      |      |      |
| PROCESSING?           |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| *(THE OPERATOR SHOULD |                       |      |      |      |
| VISUALLY MONITOR THE  |                       |      |      |      |
| MIG THERMOMETER AT    |                       |      |      |      |
| THE END OF THE        |                       |      |      |      |
| COME-UP TIME (START   |                       |      |      |      |
| OF THERMAL PROCESS)   |                       |      |      |      |
| AND DURING THE        |                       |      |      |      |
| PROCESS)*             |                       |      |      |      |
|                       |                       |      |      |      |
| *(THE RECORDING       |                       |      |      |      |
| THERMOMETER CHART     |                       |      |      |      |
| SHALL BE ADJUSTED TO  |                       |      |      |      |
| AGREE AS NEARLY AS    |                       |      |      |      |
| POSSIBLE WITH BUT NOT |                       |      |      |      |
| BE HIGHER THAN THE    |                       |      |      |      |
| MIG THERMOMETER       |                       |      |      |      |
| DURING THE PROCESSING |                       |      |      |      |
| PERIOD                |                       |      |      |      |
| (113.40(a)(2))*       |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 48\. IS THE STEAM     |                       |      |      |      |
| SUPPLY (PRESSURE) TO  |                       |      |      |      |
| THE RETORTS           |                       |      |      |      |
| SUFFICIENT TO ASSURE  |                       |      |      |      |
| AN ADEQUATE COME-UP   |                       |      |      |      |
| AND THERMAL PROCESS?  |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 49\. OBSERVE A FULL   |                       |      |      |      |
| RETORT CYCLE USING A  |                       |      |      |      |
| CALIBRATED STOPWATCH. |                       |      |      |      |
|                       |                       |      |      |      |
| COMPARE YOUR          |                       |      |      |      |
| OBSERVATIONS WITH THE |                       |      |      |      |
| FILED AND POSTED      |                       |      |      |      |
| PROCESSES. DOES YOUR  |                       |      |      |      |
| OBSERVATIONS OF THE   |                       |      |      |      |
| VENT TIME/COME-UP     |                       |      |      |      |
| TIME AND TEMPERATURE  |                       |      |      |      |
| AND THE PROCESS TIME  |                       |      |      |      |
| AND TEMPERATURE       |                       |      |      |      |
| AGREE\                |                       |      |      |      |
| WITH OR EXCEED THE    |                       |      |      |      |
| VENT AND SCHEDULED    |                       |      |      |      |
| PROCESSES ESTABLISHED |                       |      |      |      |
| BY THE PROCESS        |                       |      |      |      |
| AUTHORITY AND FILED   |                       |      |      |      |
| WITH FDA? Yes No      |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **POST PROCESS        |                       |      |      |      |
| HANDLING**            |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 50\. ARE POST PROCESS |                       |      |      |      |
| CAN CONVEYOR TRACKS   |                       |      |      |      |
| MAINTAINED SANITARY?  |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| *(CONVEYOR TRACKS     |                       |      |      |      |
| SHOULD BE CLEAN ,     |                       |      |      |      |
| SANITIZED AND DRY)*   |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 51\. IS RETORT        |                       |      |      |      |
| COOLING WATER         |                       |      |      |      |
| RECIRCULATED OR HELD  |                       |      |      |      |
| IN A COOLING CANAL?   |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 52\. IS RETORT        |                       |      |      |      |
| COOLING WATER TREATED |                       |      |      |      |
| WITH CHLORINE OR      |                       |      |      |      |
| OTHER SANITIZER (S)?  |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| *LIST THE SANITIZER   |                       |      |      |      |
| (S) USED IN THE       |                       |      |      |      |
| FIRM'S COOLING WATER  |                       |      |      |      |
| AND THE CONCENTRATION |                       |      |      |      |
| LEVEL (MEASURED       |                       |      |      |      |
| DURING THIS           |                       |      |      |      |
| INSPECTION) AT THE    |                       |      |      |      |
| WATER DISCHARGE END.* |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
| *(CONTAINER COOLING   |                       |      |      |      |
| WATER SHALL BE        |                       |      |      |      |
| CHLORINATED OR        |                       |      |      |      |
| OTHERWISE SANITIZED   |                       |      |      |      |
| AS NECESSARY FOR      |                       |      |      |      |
| COOLING CANALS AND    |                       |      |      |      |
| FOR RECIRCULATED      |                       |      |      |      |
| WATER SUPPLIES; THERE |                       |      |      |      |
| SHOULD BE A           |                       |      |      |      |
| MEASURABLE RESIDUAL   |                       |      |      |      |
| OF THE SANITIZER AT   |                       |      |      |      |
| THE\                  |                       |      |      |      |
| WATER DISCHARGE POINT |                       |      |      |      |
| OF THE CONTAINER      |                       |      |      |      |
| COOLER --             |                       |      |      |      |
| 113.60(b)).*          |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 53\. ARE CONTAINER    |                       |      |      |      |
| HANDLING PROCEDURES   |                       |      |      |      |
| AND CONVEYANCE        |                       |      |      |      |
| EQUIPMENT ADEQUATE TO |                       |      |      |      |
| PROTECT THE CONTAINER |                       |      |      |      |
| BODY AND SEALS FROM   |                       |      |      |      |
| DAMAGE THAT COULD     |                       |      |      |      |
| RESULT IN LEAKAGE AND |                       |      |      |      |
| POST PROCESS          |                       |      |      |      |
| CONTAMINATION? Yes No |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 54\. WHAT IS THE      |                       |      |      |      |
| FIRM'S PROCEDURE IF   |                       |      |      |      |
| CONTAINER DEFECTS ARE |                       |      |      |      |
| FOUND AFTER THERMAL   |                       |      |      |      |
| PROCESSING TO ASSURE  |                       |      |      |      |
| THAT THE LOT IS SAFE  |                       |      |      |      |
| FOR DISTRIBUTION?     |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 55\. EXAMINE ANY      |                       |      |      |      |
| SUSPECT PRODUCT CODES |                       |      |      |      |
| IDENTIFIED THROUGH    |                       |      |      |      |
| RECORD REVIEW. IF NO  |                       |      |      |      |
| LOTS ARE\             |                       |      |      |      |
| SUSPECT, RANDOMLY     |                       |      |      |      |
| SELECT SEVERAL CODES  |                       |      |      |      |
| FOR VISUAL            |                       |      |      |      |
| EXAMINATION. REPORT   |                       |      |      |      |
| THE RESULTS OF THE    |                       |      |      |      |
| FIELD EXAMINATION IN  |                       |      |      |      |
| THE COMMENTS FIELD    |                       |      |      |      |
| BELOW. IF ABNORMAL    |                       |      |      |      |
| CONTAINERS ARE        |                       |      |      |      |
| IDENTIFIED THROUGH    |                       |      |      |      |
| WAREHOUSE             |                       |      |      |      |
| EXAMINATION, REVIEW   |                       |      |      |      |
| THE CORRESPONDING     |                       |      |      |      |
| PROCESSING AND        |                       |      |      |      |
| CONTAINER INSPECTION  |                       |      |      |      |
| RECORDS. SAMPLE       |                       |      |      |      |
| ABNORMAL LOTS         |                       |      |      |      |
| FOLLOWING IOM SAMPLE  |                       |      |      |      |
| SCHEDULE CHART 2.     |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **RECORDS --          |                       |      |      |      |
| 113.100**             |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 56\. IS PROCESSING    |                       |      |      |      |
| AND PRODUCTION        |                       |      |      |      |
| INFORMATION RECORDED  |                       |      |      |      |
| AT THE TIME IT IS     |                       |      |      |      |
| OBSERVED BY THE       |                       |      |      |      |
| RETORT OPERATOR?      |                       |      |      |      |
| 113.100(b) Yes No     |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 57\. DO PROCESSING    |                       |      |      |      |
| AND PRODUCTION        |                       |      |      |      |
| RECORDS INCLUDE THE   |                       |      |      |      |
| PRODUCT, PRODUCT      |                       |      |      |      |
| CODE, DATE, RETORT    |                       |      |      |      |
| NO., APPROX. NUMBER   |                       |      |      |      |
| OF CONTAINERS PER     |                       |      |      |      |
| CODING INTERVAL,      |                       |      |      |      |
| INITIAL TEMPERATURE,  |                       |      |      |      |
| ACTUAL PROCESSING     |                       |      |      |      |
| TIME, MIG AND         |                       |      |      |      |
| RECORDING THERMOMETER |                       |      |      |      |
| READINGS AND OTHER    |                       |      |      |      |
| APPROPRIATE           |                       |      |      |      |
| PROCESSING DATA PER   |                       |      |      |      |
| PART 113.100(a)? Yes  |                       |      |      |      |
| No                    |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 58\. ARE RECORDING    |                       |      |      |      |
| THERMOMETER CHARTS    |                       |      |      |      |
| IDENTIFIED BY DATE,   |                       |      |      |      |
| RETORT NUMBER, AND    |                       |      |      |      |
| OTHER DATA AS         |                       |      |      |      |
| NECESSARY SO THEY CAN |                       |      |      |      |
| BE CORRELATED WITH    |                       |      |      |      |
| THE WRITTEN RECORD OF |                       |      |      |      |
| LOTS PROCESSED? --    |                       |      |      |      |
| 113.100(b)            |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 59\. ARE PROCESSING   |                       |      |      |      |
| AND PRODUCTION        |                       |      |      |      |
| RECORDS SIGNED OR     |                       |      |      |      |
| INITIALED BY THE      |                       |      |      |      |
| RETORT OPERATOR AND   |                       |      |      |      |
| REVIEWED FOR          |                       |      |      |      |
| COMPLETENESS & SIGNED |                       |      |      |      |
| OR INITIALED AND      |                       |      |      |      |
| DATED BY PLANT        |                       |      |      |      |
| MANAGEMENT WITHIN 1   |                       |      |      |      |
| WORKING DAY AFTER THE |                       |      |      |      |
| ACTUAL PROCESS TO     |                       |      |      |      |
| ASSURE THAT THE       |                       |      |      |      |
| PRODUCT RECEIVED THE  |                       |      |      |      |
| SCHEDULED PROCESS? -- |                       |      |      |      |
| 113.100(b) Yes No     |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 60\. ARE THE RESULTS  |                       |      |      |      |
| OF VISUAL AND         |                       |      |      |      |
| DESTRUCTIVE CONTAINER |                       |      |      |      |
| INTEGRITY TESTS       |                       |      |      |      |
| DOCUMENTED PER PART   |                       |      |      |      |
| 113.60(a)? ) Yes No   |                       |      |      |      |
|                       |                       |      |      |      |
| *(WRITTEN RECORDS     |                       |      |      |      |
| SHALL SPECIFY THE     |                       |      |      |      |
| PRODUCT CODE, THE     |                       |      |      |      |
| DATE AND TIME OF      |                       |      |      |      |
| CONTAINER CLOSURE     |                       |      |      |      |
| INSPECTIONS,\         |                       |      |      |      |
| THE MEASUREMENTS      |                       |      |      |      |
| OBTAINED, AND ALL     |                       |      |      |      |
| CORRECTIVE ACTIONS    |                       |      |      |      |
| TAKEN; THE RECORDS    |                       |      |      |      |
| SHALL BE SIGNED OR    |                       |      |      |      |
| INITIALED\            |                       |      |      |      |
| BY THE CONTAINER      |                       |      |      |      |
| CLOSURE INSPECTOR AND |                       |      |      |      |
| REVIEWED BY           |                       |      |      |      |
| MANAGEMENT WITH       |                       |      |      |      |
| SUFFICIENT FREQUENCY  |                       |      |      |      |
| TO ASSURE\            |                       |      |      |      |
| THE CONTAINERS ARE    |                       |      |      |      |
| HERMETICALLY SEALED   |                       |      |      |      |
| -- 113.100(c)).*      |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 61\. REVIEW A SELECT  |                       |      |      |      |
| NUMBER OF PROCESSING  |                       |      |      |      |
| RECORDS (RETORT LOGS, |                       |      |      |      |
| RECORDING             |                       |      |      |      |
| THERMOMETER\          |                       |      |      |      |
| CHARTS, RECORDS OF    |                       |      |      |      |
| OTHER CRITICAL FACTOR |                       |      |      |      |
| MONITORING), AND      |                       |      |      |      |
| CONTAINER INTEGRITY   |                       |      |      |      |
| TEST RECORDS (BOTH    |                       |      |      |      |
| VISUAL AND TEARDOWN   |                       |      |      |      |
| INSPECTION RECORDS)   |                       |      |      |      |
| REPRESENTATIVE OF UP  |                       |      |      |      |
| TO 7 PRODUCTION\      |                       |      |      |      |
| DAYS DURING A 3 MONTH |                       |      |      |      |
| PERIOD, IF AVAILABLE, |                       |      |      |      |
| IMMEDIATELY PRIOR TO  |                       |      |      |      |
| THIS INSPECTION.      |                       |      |      |      |
| FOLLOW THE PROCEDURES |                       |      |      |      |
| FOR SELECTING RECORDS |                       |      |      |      |
| OUTLINED ON PAGE 83   |                       |      |      |      |
| (ATTACHMENT 12) OF    |                       |      |      |      |
| LACF INSPECTION       |                       |      |      |      |
| GUIDE-PART 2.         |                       |      |      |      |
|                       |                       |      |      |      |
| DID THE REVIEW OF     |                       |      |      |      |
| THESE RECORDS         |                       |      |      |      |
| DISCLOSE ANY          |                       |      |      |      |
| DEVIATIONS FROM PART  |                       |      |      |      |
| 113 OR ANY            |                       |      |      |      |
| DEFICIENCIES OR       |                       |      |      |      |
| INFORMATION           |                       |      |      |      |
| INDICATING THAT ANY   |                       |      |      |      |
| LOT OF LACF PRODUCED  |                       |      |      |      |
| AT THIS ESTABLISHMENT |                       |      |      |      |
| MAY HAVE THERMAL      |                       |      |      |      |
| PROCESS DEVIATIONS OR |                       |      |      |      |
| CONTAINER INTEGRITY   |                       |      |      |      |
| DEFICIENCIES? Yes No  |                       |      |      |      |
|                       |                       |      |      |      |
| IF YES, EXPLAIN IN    |                       |      |      |      |
| "COMMENTS" BELOW.     |                       |      |      |      |
| REPORT THE TYPE AND   |                       |      |      |      |
| DATES OF RECORDS      |                       |      |      |      |
| REVIEWED.             |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 62\. ARE COPIES OF    |                       |      |      |      |
| ALL RECORDS PROVIDED  |                       |      |      |      |
| FOR IN PART 113       |                       |      |      |      |
| EXCEPT THOSE          |                       |      |      |      |
| PERTAINING TO THE     |                       |      |      |      |
| ESTABLISHMENT OF      |                       |      |      |      |
| SCHEDULED PROCESSES   |                       |      |      |      |
| RETAINED AT THE       |                       |      |      |      |
| PROCESSING PLANT FOR  |                       |      |      |      |
| AT LEAST 1 YEAR FROM  |                       |      |      |      |
| THE DATE OF           |                       |      |      |      |
| MANUFACTURE AND AT    |                       |      |      |      |
| THE PROCESSING PLANT  |                       |      |      |      |
| OR OTHER REASONABLY   |                       |      |      |      |
| ACCESSIBLE LOCATION   |                       |      |      |      |
| FOR AN ADDITIONAL 2   |                       |      |      |      |
| YEARS? -- 113.100(e)  |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **PROCESS DEVIATIONS  |                       |      |      |      |
| -- 113.89**           |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 63\. DOES THE FIRM    |                       |      |      |      |
| HAVE A WRITTEN        |                       |      |      |      |
| PROCEDURE FOR         |                       |      |      |      |
| HANDLING PROCESS      |                       |      |      |      |
| DEVIATIONS? Yes No    |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 64\. DOES THE FIRM    |                       |      |      |      |
| MAINTAIN A SEPARATE   |                       |      |      |      |
| FILE OR LOG FOR       |                       |      |      |      |
| DOCUMENTING PROCESS   |                       |      |      |      |
| DEVIATIONS?           |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 65\. WERE ANY PROCESS |                       |      |      |      |
| DEVIATIONS NOTED      |                       |      |      |      |
| DURING THE            |                       |      |      |      |
| INSPECTION? Yes No    |                       |      |      |      |
|                       |                       |      |      |      |
| IF SO, WERE THE       |                       |      |      |      |
| DEVIATIONS PROPERLY   |                       |      |      |      |
| HANDLED? Yes No       |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 66\. WERE ANY PROCESS |                       |      |      |      |
| DEVIANT LOTS (NOT     |                       |      |      |      |
| PROPERLY HANDLED)     |                       |      |      |      |
| SHIPPED INTERSTATE?   |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| IF SO, WAS FDA        |                       |      |      |      |
| NOTIFIED? --          |                       |      |      |      |
| 108.35(d&e) Yes No    |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 67\. DOES MANAGEMENT  |                       |      |      |      |
| FULLY UNDERSTAND THE  |                       |      |      |      |
| DEFINITION AND        |                       |      |      |      |
| MEANING OF THE TERM   |                       |      |      |      |
| "PROCESS\             |                       |      |      |      |
| DEVIATION" AND        |                       |      |      |      |
| PROCEDURES FOR        |                       |      |      |      |
| HANDLING THEM AS      |                       |      |      |      |
| DEFINED AND STATED IN |                       |      |      |      |
| 113.89? Yes No        |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **INCUBATION --       |                       |      |      |      |
| 113.40(g)(3)**        |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 68\. ARE THE RESULTS  |                       |      |      |      |
| OF INCUBATION TESTS   |                       |      |      |      |
| RECORDED? Yes No      |                       |      |      |      |
|                       |                       |      |      |      |
| DESCRIBE ANY          |                       |      |      |      |
| INCUBATION TESTS      |                       |      |      |      |
| PERFORMED ON FINISHED |                       |      |      |      |
| PRODUCTION LOTS       |                       |      |      |      |
| (INCLUDE SAMPLING,    |                       |      |      |      |
| INCUBATION AND TEST   |                       |      |      |      |
| PROCEDURES):          |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
| IF POSITIVE RESULTS   |                       |      |      |      |
| ARE FOUND, WHAT       |                       |      |      |      |
| FOLLOW-UP ACTION DOES |                       |      |      |      |
| THE FIRM TAKE TO      |                       |      |      |      |
| ASSURE THAT THE       |                       |      |      |      |
| AFFECTED LOT IS SAFE  |                       |      |      |      |
| FOR DISTRIBUTION?     |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
|                       |                       |      |      |      |
| *NOTE -- INCUBATION   |                       |      |      |      |
| TESTING IS            |                       |      |      |      |
| RECOMMENDED BUT NOT   |                       |      |      |      |
| REQUIRED FOR          |                       |      |      |      |
| ASEPTICALLY PROCESSED |                       |      |      |      |
| PRODUCTS --           |                       |      |      |      |
| 113.40(g)(3).*        |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **PERSONNEL --        |                       |      |      |      |
| 108.35/113.10**       |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 69\. ARE ALL          |                       |      |      |      |
| OPERATORS OF THERMAL  |                       |      |      |      |
| PROCESSING SYSTEMS    |                       |      |      |      |
| AND CONTAINER CLOSURE |                       |      |      |      |
| INSPECTIONS UNDER THE |                       |      |      |      |
| OPERATING SUPERVISION |                       |      |      |      |
| OF A PERSON WHO HAS   |                       |      |      |      |
| ATTENDED A SCHOOL     |                       |      |      |      |
| APPROVED BY FDA?      |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **PLANT AND EQUIPMENT |                       |      |      |      |
| SANITATION --         |                       |      |      |      |
| 110.35/40**           |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 70\. IS PLANT AND     |                       |      |      |      |
| EQUIPMENT SANITATION  |                       |      |      |      |
| ADEQUATE TO PREVENT   |                       |      |      |      |
| THE ADULTERATION OF   |                       |      |      |      |
| FOOD WITH\            |                       |      |      |      |
| PHYSICAL, CHEMICAL OR |                       |      |      |      |
| MICROBIOLOGICAL       |                       |      |      |      |
| CONTAMINANTS? Yes No  |                       |      |      |      |
|                       |                       |      |      |      |
| *(SUMMARIZE THE       |                       |      |      |      |
| FIRM'S PROCEDURES FOR |                       |      |      |      |
| CLEANING AND          |                       |      |      |      |
| SANITIZING FOOD       |                       |      |      |      |
| CONTACT EQUIPMENT     |                       |      |      |      |
| BOTH PRE AND POST     |                       |      |      |      |
| PROCESS)*             |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| **RECALL PROCEDURES** |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 71. DOES THE FIRM     |                       |      |      |      |
|     HAVE PREPARED     |                       |      |      |      |
|     RECALL PROCEDURES |                       |      |      |      |
|     ON FILE THAT      |                       |      |      |      |
|     COMPLY WITH       |                       |      |      |      |
|     108.35(f)?        |                       |      |      |      |
|                       |                       |      |      |      |
| Yes No                |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
|                       |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+
| 72\. DOES THE FIRM    |                       |      |      |      |
| MAINTAIN INITIAL      |                       |      |      |      |
| DISTRIBUTION RECORDS  |                       |      |      |      |
| PER 113.100(d)? Yes   |                       |      |      |      |
| No                    |                       |      |      |      |
|                       |                       |      |      |      |
| COMMENTS:             |                       |      |      |      |
|                       |                       |      |      |      |
| >                     |                       |      |      |      |
+-----------------------+-----------------------+------+------+------+