+-----------------------+-----------------------+-------+-------+-------+
| **Firm Name:**        |                       |       |       |       |
| **FEI Number:**       |                       |       |       |       |
|                       |                       |       |       |       |
| **Inspection          |                       |       |       |       |
| Date(s):**            |                       |       |       |       |
| **FCE Number:**       |                       |       |       |       |
|                       |                       |       |       |       |
| **Investigators:**    |                       |       |       |       |
|                       |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| DEPARTMENT OF HEALTH  |                       |       |       |       |
| AND HUMAN SERVICES    |                       |       |       |       |
|                       |                       |       |       |       |
| FOOD AND DRUG         |                       |       |       |       |
| ADMINISTRATION        |                       |       |       |       |
|                       |                       |       |       |       |
| **FDA ACIDIFIED FOOD  |                       |       |       |       |
| 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\. HAVE PROCESSES    |                       |       |       |       |
| BEEN ESTABLISHED FOR  |                       |       |       |       |
| ALL ACIDIFIED FOODS   |                       |       |       |       |
| PROCESSED AT THIS     |                       |       |       |       |
| FACILITY? -- Part\    |                       |       |       |       |
| 114.83 Yes No         |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 2\. HAS THE FIRM      |                       |       |       |       |
| REGISTERED WITH FDA   |                       |       |       |       |
| AND FILED A PROCESS   |                       |       |       |       |
| FOR ALL ACIDIFIED     |                       |       |       |       |
| FOODS PROCESSED AT\   |                       |       |       |       |
| THIS FACILITY? --     |                       |       |       |       |
| 108.25(c) Yes No      |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 3\. 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   |                       |       |       |       |
| > THAT THE FIRM       |                       |       |       |       |
| > CONTROLS BUT HAVE   |                       |       |       |       |
| > NOT BEEN IDENTIFIED |                       |       |       |       |
| > IN THE PROCESS\     |                       |       |       |       |
| > FILING. CRITICAL    |                       |       |       |       |
| > FACTORS MAY ALSO    |                       |       |       |       |
| > EXIST THAT HAVE OR  |                       |       |       |       |
| > HAVE NOT BEEN       |                       |       |       |       |
| > IDENTIFIED AND ARE  |                       |       |       |       |
| > NOT CONTROLLED.     |                       |       |       |       |
| > COMPARE MINIMUM     |                       |       |       |       |
| > EQUILIBRIUM PH AND  |                       |       |       |       |
| > OTHER CRITICAL      |                       |       |       |       |
| > FACTORS LISTED ON   |                       |       |       |       |
| > PROCESS FILING      |                       |       |       |       |
| > FORMS WITH SIMILAR  |                       |       |       |       |
| > INFORMATION LISTED  |                       |       |       |       |
| > IN PROCESS LETTERS  |                       |       |       |       |
| > OR OTHER PROCESS    |                       |       |       |       |
| > SOURCE              |                       |       |       |       |
| > DOCUMENTATION.)*    |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 4\. 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 CAN    |                       |       |       |       |
| AFFECT THE ATTAINMENT |                       |       |       |       |
| OF COMMERCIAL         |                       |       |       |       |
| STERILITY FOR         |                       |       |       |       |
| ACIDIFIED FOODS.\     |                       |       |       |       |
| FOR EXAMPLE, A CHANGE |                       |       |       |       |
| IN THE FORMULATION    |                       |       |       |       |
| SUCH AS SIZE OF SOLID |                       |       |       |       |
| PIECES, THE SOLID TO  |                       |       |       |       |
| LIQUID RATIO OR THE\  |                       |       |       |       |
| TYPE AND/OR QUANTITY  |                       |       |       |       |
| OF ACID USED COULD    |                       |       |       |       |
| AFFECT THE FINISHED   |                       |       |       |       |
| EQUILIBRIUM PH.)*     |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| **PROCESS DELIVERY**  |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 5\. ARE RAW PRODUCT   |                       |       |       |       |
| MATERIALS PREPARED    |                       |       |       |       |
| ACCORDING TO THE      |                       |       |       |       |
| METHOD (GRADING,      |                       |       |       |       |
| WASHING, HYDRATING,   |                       |       |       |       |
| BLANCHING), ETC.      |                       |       |       |       |
| AND/OR FORMULATION    |                       |       |       |       |
| SPECIFIED IN THE      |                       |       |       |       |
| RECOMMENDED SCHEDULED |                       |       |       |       |
| PROCESS?              |                       |       |       |       |
|                       |                       |       |       |       |
| Yes No                |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| DESCRIBE THE FIRM'S   |                       |       |       |       |
| PROCEDURES FOR        |                       |       |       |       |
| HANDLING/PREPARING    |                       |       |       |       |
| RAW MATERIALS AND     |                       |       |       |       |
| PRODUCT PREPARATION:  |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 6\. THERE ARE SEVERAL |                       |       |       |       |
| METHODS USED TO       |                       |       |       |       |
| ACIDIFY LOW-ACID      |                       |       |       |       |
| FOODS INCLUDING:      |                       |       |       |       |
| BLANCHING IN ACID     |                       |       |       |       |
| SOLUTIONS, IMMERSION  |                       |       |       |       |
| OF BLANCHED FOODS IN  |                       |       |       |       |
| ACID SOLUTIONS,       |                       |       |       |       |
| DIRECT BATCH          |                       |       |       |       |
| ACIDIFICATION,        |                       |       |       |       |
| ADDITION\             |                       |       |       |       |
| OF ACID DIRECTLY TO   |                       |       |       |       |
| INDIVIDUAL            |                       |       |       |       |
| CONTAINERS, AND       |                       |       |       |       |
| ADDITION OF ACID      |                       |       |       |       |
| FOODS TO LOW-ACID     |                       |       |       |       |
| FOODS.                |                       |       |       |       |
|                       |                       |       |       |       |
| ARE PRODUCTS          |                       |       |       |       |
| ACIDIFIED ACCORDING   |                       |       |       |       |
| TO THE METHOD AND/OR  |                       |       |       |       |
| FORMULATION SPECIFIED |                       |       |       |       |
| IN THE RECOMMENDED    |                       |       |       |       |
| SCHEDULED PROCESS?    |                       |       |       |       |
| Yes No                |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
|                       |                       |       |       |       |
| DESCRIBE THE FIRM'S   |                       |       |       |       |
| PROCEDURES FOR        |                       |       |       |       |
| ACIDIFICATION:        |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 7\. DOES THE FIRM     |                       |       |       |       |
| ADEQUATELY CONTROL pH |                       |       |       |       |
| TO ENSURE THAT THE    |                       |       |       |       |
| EQUILIBRIUM pH OF     |                       |       |       |       |
| FINISHED PRODUCTS     |                       |       |       |       |
| DOES NOT EXCEED THE   |                       |       |       |       |
| MAXIMUM VALUE         |                       |       |       |       |
| SPECIFIED IN THE      |                       |       |       |       |
| SCHEDULED PROCESS?    |                       |       |       |       |
| Yes No                |                       |       |       |       |
|                       |                       |       |       |       |
| pH IS MONITORED       |                       |       |       |       |
| USING: Poteniometric  |                       |       |       |       |
| Colorimetric Other    |                       |       |       |       |
| methods               |                       |       |       |       |
|                       |                       |       |       |       |
| IF A pH METER IS      |                       |       |       |       |
| USED, IT IS           |                       |       |       |       |
| STANDARDIZED AND      |                       |       |       |       |
| ACCURATE Yes No       |                       |       |       |       |
|                       |                       |       |       |       |
| pH MONITORING RECORDS |                       |       |       |       |
| ARE PREPARED AND      |                       |       |       |       |
| MAINTAINED Yes No     |                       |       |       |       |
|                       |                       |       |       |       |
| *(THE FIRM MUST       |                       |       |       |       |
| FREQUENTLY MONITOR PH |                       |       |       |       |
| (114.80(A)(2)) AND    |                       |       |       |       |
| PREPARE/MAINTAIN      |                       |       |       |       |
| RECORDS 114.100(B);   |                       |       |       |       |
| IF A PH\              |                       |       |       |       |
| METER IS USED, IT     |                       |       |       |       |
| SHOULD BE ACCURATE,   |                       |       |       |       |
| ADEQUATELY EQUIPPED   |                       |       |       |       |
| AND STANDARDIZED TO   |                       |       |       |       |
| ENSURE IT'S ACCURACY. |                       |       |       |       |
| PROPER PROCEDURES     |                       |       |       |       |
| SHOULD BE FOLLOWED IN |                       |       |       |       |
| OPERATION OF THE PH   |                       |       |       |       |
| METER AS PROVIDED BY  |                       |       |       |       |
| THE INSTRUMENT        |                       |       |       |       |
| MANUFACTURER AND      |                       |       |       |       |
| SPECIFIED IN PART     |                       |       |       |       |
| 114.90                |                       |       |       |       |
| (11                   |                       |       |       |       |
| 4.90(A),110.40(F)).)* |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 8\. LIST ALL FACTORS  |                       |       |       |       |
| CRITICAL TO THE       |                       |       |       |       |
| ATTAINMENT OF         |                       |       |       |       |
| COMMERCIAL STERILITY  |                       |       |       |       |
| PER PROCESS AUTHORITY |                       |       |       |       |
| LETTER AND FILING     |                       |       |       |       |
| FORM(S) FOR PRODUCTS  |                       |       |       |       |
| COVERED DURING THIS   |                       |       |       |       |
| INSPECTION (INCLUDE   |                       |       |       |       |
| MAX\                  |                       |       |       |       |
| EQUILIBRIUM pH,       |                       |       |       |       |
| PROCESS TIME/TEMP AND |                       |       |       |       |
| ALL OTHER CRITICAL    |                       |       |       |       |
| FACTORS:              |                       |       |       |       |
|                       |                       |       |       |       |
| *(LIST MINIMUM        |                       |       |       |       |
| SCHEDULED PROCESS     |                       |       |       |       |
| BELOW AS FILED WITH   |                       |       |       |       |
| FDA.)*                |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
|                       |                       | *     |       |       |
|                       |                       | **CRI |       |       |
|                       |                       | TICAL |       |       |
|                       |                       | FACTO |       |       |
|                       |                       | RS*** |       |       |
+-----------------------+-----------------------+-------+-------+-------+
|                       |                       | *     | *     | *     |
|                       |                       | Max.* | Min.\ | Min.\ |
|                       |                       |       | Pro   | Pro   |
|                       |                       | *pH*  | cess\ | cess\ |
|                       |                       |       | Time* | T     |
|                       |                       |       |       | emp.* |
+-----------------------+-----------------------+-------+-------+-------+
| > ***PRODUCT***       | ***CONTAINER          |       |       |       |
| >                     | TYPE/SIZE***          |       |       |       |
| >                     |                       |       |       |       |
|                       |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
|                       |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| COMMENTS, INCLUDING   |                       |       |       |       |
| OTHER CRITICAL        |                       |       |       |       |
| FACTORS:              |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 9\. OBSERVE THE       |                       |       |       |       |
| PRODUCTION OF A BATCH |                       |       |       |       |
| OF ACIDIFIED FOOD     |                       |       |       |       |
| PRODUCT. DETERMINE IF |                       |       |       |       |
| ALL CRITICAL\         |                       |       |       |       |
| FACTORS LISTED ON     |                       |       |       |       |
| FORM 2541a AND IN ANY |                       |       |       |       |
| PROCESS SOURCE        |                       |       |       |       |
| DOCUMENT ARE BEING    |                       |       |       |       |
| MONITORED AND\        |                       |       |       |       |
| THE RESULTS RECORDED. |                       |       |       |       |
| DETERMINE IF CRITICAL |                       |       |       |       |
| FACTORS (SUCH AS MAX  |                       |       |       |       |
| EQUILIBRIUM pH, SOLID |                       |       |       |       |
| TO\                   |                       |       |       |       |
| LIQUID RATIO, MIN     |                       |       |       |       |
| THERMAL PROCESS TIME  |                       |       |       |       |
| & TEMP) ARE BEING     |                       |       |       |       |
| ACHIEVED.             |                       |       |       |       |
|                       |                       |       |       |       |
| CRITICAL FACTORS      |                       |       |       |       |
| UNDER CONTROL Yes No  |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 10\. 114.80 (A) (1)   |                       |       |       |       |
| REQUIRES ACIDIFIED    |                       |       |       |       |
| FOODS TO BE THERMALLY |                       |       |       |       |
| PROCESSED TO DESTROY  |                       |       |       |       |
| THE VEGETATIVE CELLS  |                       |       |       |       |
| OF MICROORGANISM OF   |                       |       |       |       |
| PUBLIC HEALTH         |                       |       |       |       |
| SIGNIFICANCE AND      |                       |       |       |       |
| THOSE OF NON-HEALTH   |                       |       |       |       |
| SIGNIFICANCE CAPABLE  |                       |       |       |       |
| OF REPRODUCING IN THE |                       |       |       |       |
| FOOD UNDER NORMAL     |                       |       |       |       |
| CONDITIONS OF         |                       |       |       |       |
| STORAGE. ORGANISMS    |                       |       |       |       |
| OF\                   |                       |       |       |       |
| NON-HEALTH            |                       |       |       |       |
| SIGNIFICANCE MAY BE   |                       |       |       |       |
| CONTROLLED BY         |                       |       |       |       |
| PRESERVATIVES. THERE  |                       |       |       |       |
| ARE SEVERAL DIFFERENT |                       |       |       |       |
| METHODS AND EQUIPMENT |                       |       |       |       |
| THAT CAN BE USED TO   |                       |       |       |       |
| THERMALLY PROCESS     |                       |       |       |       |
| ACIDIFIED FOODS       |                       |       |       |       |
| INCLUDING: HOT FILL   |                       |       |       |       |
| AND HOLD, STILL WATER |                       |       |       |       |
| IMMERSION, CONTINUOUS |                       |       |       |       |
| CONTAINER             |                       |       |       |       |
| PASTEURIZATION, HEAT  |                       |       |       |       |
| EXCHANGERS, AND       |                       |       |       |       |
| ASEPTIC HEATING AND   |                       |       |       |       |
| PACKAGING.            |                       |       |       |       |
|                       |                       |       |       |       |
| WHAT TYPE OF THERMAL  |                       |       |       |       |
| PROCESS DOES THE FIRM |                       |       |       |       |
| USE?                  |                       |       |       |       |
|                       |                       |       |       |       |
| HOT FILL AND HOLD Yes |                       |       |       |       |
| No                    |                       |       |       |       |
|                       |                       |       |       |       |
| STILL IMMERSION Yes   |                       |       |       |       |
| No                    |                       |       |       |       |
|                       |                       |       |       |       |
| CONTINUOUS CONTAINER  |                       |       |       |       |
| Yes No                |                       |       |       |       |
|                       |                       |       |       |       |
| HEAT EXCHANGER Yes No |                       |       |       |       |
|                       |                       |       |       |       |
| ASEPTIC HEATING &     |                       |       |       |       |
| PACKAGING Yes No      |                       |       |       |       |
|                       |                       |       |       |       |
| OTHER (EXPLAIN) Yes   |                       |       |       |       |
| No                    |                       |       |       |       |
|                       |                       |       |       |       |
| DESCRIBE FIRMS        |                       |       |       |       |
| HEATING PROCEDURES:   |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
|                       |                       |       |       |       |
| OTHER COMMENTS:       |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 11\. DOES THE FIRM    |                       |       |       |       |
| USE PRESERVATIVES TO  |                       |       |       |       |
| PREVENT THE GROWTH OF |                       |       |       |       |
| MICROORGANISMS OF     |                       |       |       |       |
| NON-HEALTH            |                       |       |       |       |
| SIGNIFICANCE? Yes No  |                       |       |       |       |
|                       |                       |       |       |       |
| ARE THESE             |                       |       |       |       |
| PRESERVATIVES USED IN |                       |       |       |       |
| ACCORDANCE WITH FDA   |                       |       |       |       |
| FOOD ADDITIVE         |                       |       |       |       |
| REGULATIONS?          |                       |       |       |       |
|                       |                       |       |       |       |
| Yes No                |                       |       |       |       |
|                       |                       |       |       |       |
| LIST THE              |                       |       |       |       |
| PRESERVATIVES AND     |                       |       |       |       |
| LEVELS OF USE:        |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 12\. WERE ANY PROCESS |                       |       |       |       |
| DEVIATIONS NOTED      |                       |       |       |       |
| DURING THE            |                       |       |       |       |
| INSPECTION? Yes No    |                       |       |       |       |
|                       |                       |       |       |       |
| IF SO, WERE THE       |                       |       |       |       |
| DEVIATIONS PROPERLY   |                       |       |       |       |
| HANDLED? Yes No       |                       |       |       |       |
|                       |                       |       |       |       |
| 114.89                |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 13\. ARE CRITICAL     |                       |       |       |       |
| FACTORS MEASURED      |                       |       |       |       |
| USING ACCURATE        |                       |       |       |       |
| INSTRUMENTS? Yes No   |                       |       |       |       |
|                       |                       |       |       |       |
| *(pH METERS MUST BE   |                       |       |       |       |
| ACCURATE AND          |                       |       |       |       |
| STANDARIZED AS PER    |                       |       |       |       |
| 114.90 OR THE         |                       |       |       |       |
| MANUFACTURER'S        |                       |       |       |       |
| DIRECTIONS. EQUIPMENT |                       |       |       |       |
| USED TO MEASURE OTHER |                       |       |       |       |
| TEMPERATURES, WEIGHTS |                       |       |       |       |
| AND CRITICAL FACTORS  |                       |       |       |       |
| MUST BE ACCURATE AS   |                       |       |       |       |
| PER PART\             |                       |       |       |       |
| 110.40(f).)*          |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| **DOCUMENTATION OF    |                       |       |       |       |
| PROCESS DELIVERY**    |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 14\. DO PROCESSING    |                       |       |       |       |
| AND PRODUCTION        |                       |       |       |       |
| RECORDS INCLUDE       |                       |       |       |       |
| FINISHED PRODUCT      |                       |       |       |       |
| EQUILIBRIUM pH, ANY   |                       |       |       |       |
| OTHER CRITICAL        |                       |       |       |       |
| FACTORS PLUS          |                       |       |       |       |
| SUFFICIENT ADDITIONAL |                       |       |       |       |
| INFORMATION (PRODUCT, |                       |       |       |       |
| PRODUCT CODE, DATE,   |                       |       |       |       |
| CONTAINER SIZE, ETC.) |                       |       |       |       |
| TO PERMIT A HEALTH    |                       |       |       |       |
| HAZARD EVALUATION OF  |                       |       |       |       |
| PROCESSES APPLIED TO  |                       |       |       |       |
| EACH LOT? --          |                       |       |       |       |
| \[114.100(b)\] Yes No |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 15\. IF AVAILABLE,    |                       |       |       |       |
| REVIEW A SELECT       |                       |       |       |       |
| NUMBER OF PROCESSING  |                       |       |       |       |
| RECORDS (pH & RECORDS |                       |       |       |       |
| OF OTHER CRITICAL     |                       |       |       |       |
| FACTOR MONITORING     |                       |       |       |       |
| RECORDS),             |                       |       |       |       |
| REPRESENTATIVE OF UP  |                       |       |       |       |
| TO 7 PRODUCTION DAYS  |                       |       |       |       |
| DURING A 3 MONTH      |                       |       |       |       |
| PERIOD 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  |                       |       |       |       |
| 114 OR ANY            |                       |       |       |       |
| DEFICIENCIES OR       |                       |       |       |       |
| INFORMATION           |                       |       |       |       |
| INDICATING THAT ANY   |                       |       |       |       |
| LOT OF AF PRODUCED AT |                       |       |       |       |
| THIS ESTABLISHMENT    |                       |       |       |       |
| MAY HAVE PROCESS      |                       |       |       |       |
| DEVIATIONS? Yes No    |                       |       |       |       |
|                       |                       |       |       |       |
| IF YES, EXPLAIN IN    |                       |       |       |       |
| "COMMENTS" BELOW.     |                       |       |       |       |
| REPORT THE TYPE AND   |                       |       |       |       |
| DATES OF RECORDS      |                       |       |       |       |
| REVIEWED.             |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| **CONTAINER           |                       |       |       |       |
| INTEGRITY**           |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 16\. DOES TESTING AND |                       |       |       |       |
| EXAMINATION OF        |                       |       |       |       |
| CONTAINERS OCCUR      |                       |       |       |       |
| OFTEN ENOUGH TO       |                       |       |       |       |
| ENSURE THAT           |                       |       |       |       |
| CONTAINERS SUITABLY   |                       |       |       |       |
| PROTECT THE FOOD FROM |                       |       |       |       |
| LEAKAGE AND           |                       |       |       |       |
| CONTAMINAITON?        |                       |       |       |       |
| 114.80(a)(4) 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.)*              |                       |       |       |       |
|                       |                       |       |       |       |
| *NOTE -- PART 114     |                       |       |       |       |
| DOES NOT REQUIRE THAT |                       |       |       |       |
| THE FIRM PREPARE AND  |                       |       |       |       |
| MAINTAIN CONTAINER    |                       |       |       |       |
| INTEGRITY MONITORING  |                       |       |       |       |
| RECORDS. ENCOURAGE    |                       |       |       |       |
| THE FIRM TO DOCUMENT  |                       |       |       |       |
| THEIR CONTAINER       |                       |       |       |       |
| INTEGRITY TESTING     |                       |       |       |       |
| ACTIVITIES.*          |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 17\. 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? --     |                       |       |       |       |
| 110.40(a); 110.80 Yes |                       |       |       |       |
| No                    |                       |       |       |       |
|                       |                       |       |       |       |
| *(LIDS AND EMPTY AND  |                       |       |       |       |
| FILLED/SEALED         |                       |       |       |       |
| CONTAINERS SHOULD BE  |                       |       |       |       |
| HANDLED WITH CARE;    |                       |       |       |       |
| CONVEYANCE TRACKS     |                       |       |       |       |
| SHOULD BE CLEAN,      |                       |       |       |       |
| SANITARY AND DRY.)*   |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 18\. IS EACH          |                       |       |       |       |
| CONTAINER IDENTIFIED  |                       |       |       |       |
| WITH A VISIBLE CODE   |                       |       |       |       |
| THAT SPECIFIES THE    |                       |       |       |       |
| PACKER, THE PRODUCT   |                       |       |       |       |
| AND THE YEAR, DAY AND |                       |       |       |       |
| PERIOD OF PACK? Yes   |                       |       |       |       |
| No                    |                       |       |       |       |
|                       |                       |       |       |       |
| IS THE PACKING PERIOD |                       |       |       |       |
| CODE CHANGED OFTEN    |                       |       |       |       |
| ENOUGH TO ASSURE      |                       |       |       |       |
| READY IDENTIFICATION  |                       |       |       |       |
| OF LOTS DURING THEIR  |                       |       |       |       |
| SALE & DISTRIBUTION?  |                       |       |       |       |
| Yes No                |                       |       |       |       |
|                       |                       |       |       |       |
| 114.80(b)             |                       |       |       |       |
|                       |                       |       |       |       |
| *(THE PACKING PERIOD  |                       |       |       |       |
| CODE SHALL BE CHANGED |                       |       |       |       |
| OFTEN ENOUGH TO       |                       |       |       |       |
| ENABLE READY          |                       |       |       |       |
| IDENTIFICATION OF     |                       |       |       |       |
| LOTS DUIRNG THEIR     |                       |       |       |       |
| SALE & DISTRIBUTION.  |                       |       |       |       |
| CODES MAY BE CHANGED  |                       |       |       |       |
| PERIODICALLY AS       |                       |       |       |       |
| FOLLOWS -- AFTER      |                       |       |       |       |
| INTERVALS OF 4-5      |                       |       |       |       |
| HOURS; AFTER          |                       |       |       |       |
| PERSONNEL SHIFT       |                       |       |       |       |
| CHANGES; OR AFTER     |                       |       |       |       |
| EACH BATCH AS LONG AS |                       |       |       |       |
| ONE BATCH DOES NOT    |                       |       |       |       |
| REPRESENT MORE THAN   |                       |       |       |       |
| ONE PERSONNEL         |                       |       |       |       |
| SHIFT.)*              |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 19\. FIELD EXAMINE    |                       |       |       |       |
| INDIVIDUAL CONTAINERS |                       |       |       |       |
| OF ANY SUSPECT        |                       |       |       |       |
| PRODUCT CODES         |                       |       |       |       |
| IDENTIFIED THROUGH    |                       |       |       |       |
| INSPECTION OR RECORD  |                       |       |       |       |
| REVIEW FOLLOWING THE  |                       |       |       |       |
| PROCEDURES OUTLINED   |                       |       |       |       |
| IN THE SAMPLE         |                       |       |       |       |
| SCHEDULE\             |                       |       |       |       |
| ON P.85 OF THE LACF   |                       |       |       |       |
| INSPECTION GUIDE,     |                       |       |       |       |
| PART 2. SAMPLE        |                       |       |       |       |
| ABNORMAL LOTS         |                       |       |       |       |
| FOLLOWING THIS SAMPLE |                       |       |       |       |
| SCHEDULE.             |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 20\. DOES THE FIRM    |                       |       |       |       |
| HAVE A RECALL PLAN ON |                       |       |       |       |
| FILE? -- 108.25(e)    |                       |       |       |       |
| Yes No                |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 21\. DOES THE FIRMS   |                       |       |       |       |
| RECORDS IDENTITY      |                       |       |       |       |
| INITIAL DISTRIBUTION  |                       |       |       |       |
| OF LOTS OF PRODUCT -- |                       |       |       |       |
| 114.100 (d)           |                       |       |       |       |
|                       |                       |       |       |       |
| Yes No                |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+
| 22\. HAVE APPROPRIATE |                       |       |       |       |
| PLANT PERSONNEL       |                       |       |       |       |
| ATTENDED AND          |                       |       |       |       |
| COMPLETED A SCHOOL    |                       |       |       |       |
| APPROVED BY FDA? --   |                       |       |       |       |
| 108.25(f) Yes No      |                       |       |       |       |
|                       |                       |       |       |       |
| COMMENTS:             |                       |       |       |       |
|                       |                       |       |       |       |
| >                     |                       |       |       |       |
+-----------------------+-----------------------+-------+-------+-------+