FDA ACIDIFIED FOODS INSPECTION REPORT

(Instructions)

**This inspection report (Form 3511-1) is available for down loading on
the Internet:<http://www.fda.gov/opacom/morechoices/fdaforms/ora.html>.
The report form (in MS Word) consists of a series of expandable cell
blocks each with various headings or questions. Each cellblock is
identified numerically in the left column. Narrative responses to each
question should be entered in the cellblocks containing the questions.
Include full documentation of all deficiencies with reference to photos,
exhibits, etc.**

**Under "Objectionable Conditions/Discussion with Management", list each
objectionable observation in the same order as listed on the FDA 483.
After each item, make reference to the section (block and page number)
of the report where the item is fully explained with photos, exhibits,
etc. Provide management's response to each item in a separate paragraph
following the item.**

**The report consists of four core pages (excluding this instruction
page) and is expandable to whatever length is needed. Individual cell
blocks have been set to break across pages (to check this, first place
cursor in any cell block, then click on "Table", then "Cell Height &
Width" -- box appearing in window should be checked to allow row to
break across page).**

**Additional cellblocks can be created by the user to accommodate
additional headings. To add a cellblock, first place the cursor to the
right or left of the first line or word in the cellblock following the
block you wish to add. Then, click on "Table" in the menu at top of
screen; next, click on "Insert Rows".**

**When completed, the Summary of Findings should be copied and pasted
into FACTS. The finished report should be printed and submitted as a
hard copy report with all photos and other exhibits. This instruction
page should be deleted from the finished hard copy report. If you are
using Turbo EIR, delete any headings from this report (History of
Business, etc) that are also included in Turbo; then, copy and paste
this report directly into Turbo under a heading "LACF Report" or as an
attachment.**

**References:**

-   **Guide to Inspections of Acidified Food Manufacturers, May, 1998**

-   **Guide to Inspections of Low Acid Canned Food Manufacturers, Part
    2, Processes/Procedures, April, 1997**

-   **Guide to Inspections of Low Acid Canned Food Manufacturers Part 3
    -- Containers/Closures -- November, 1998**

-   **21CFR Part 114 --Acidified Foods**

-   **21CFR Part 108- Emergency Permit Control**

-   **21CFR Part 110 -- CGMP in Manufacturing, Packing or Holding Human
    Food**

+----+-----------------------------------------------------------------+
| #  | # FDA ACIDIFIED FOOD INSPECTION REPORT                          |
| #  |                                                                 |
|    |                                                                 |
| ## |                                                                 |
|    |                                                                 |
+----+-----------------------------------------------------------------+
| #  | # SUMMARY OF FINDINGS                                           |
| #  |                                                                 |
|  1 | (**Follow procedures in IOM Chpt 5)*)***                        |
+----+-----------------------------------------------------------------+
| *  | #### HISTORY OF BUSINESS                                        |
| *2 |                                                                 |
| ** | **(IOM Chpt 5)**                                                |
+----+-----------------------------------------------------------------+
| *  | #### PERSONS INTERVIEWED & INDIVIDUAL RESPONSIBILITY            |
| *3 |                                                                 |
| ** | **(IOM Chpt 5)**                                                |
+----+-----------------------------------------------------------------+
| *  | #### PROCESS ESTABLISHMENT, FILING AND SCHEDULES                |
| *4 |                                                                 |
| ** |                                                                 |
+----+-----------------------------------------------------------------+
| *  | ## HAVE PROC                                                    |
| *5 | ESSES BEEN ESTABLISHED FOR ALL AFS PROCESSED AT THIS FACILITY?  |
| ** |                                                                 |
|    | #### Part 114.83 YES \[\] NO \[\]                               |
+----+-----------------------------------------------------------------+
| *  | #### HAS THE FIRM REGISTERED WITH FDA AND FILED A PROCESS FOR A |
| *6 | LL AFS PROCESSED AT THIS FACILITY? 108.25(c)\] YES \[\] NO \[\] |
| ** |                                                                 |
+----+-----------------------------------------------------------------+
| *  | **DO CRITICAL FACTORS/LIMITS LISTED IN SOURCE DOCUMENTS MATCH   |
| *7 | 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 c |
|    | ontrolled. Compare minimum equilibrium pH and other critical fa |
|    | ctors listed on process filing forms with similar information l |
|    | isted in process letters or other process source documentation* |
+----+-----------------------------------------------------------------+
| *  | **HAVE FILED, SCHEDULED PROCESSES BEEN CHANGED IN SUCH A WAY    |
| *8 | THAT COULD AFFECT THE ATTAINMENT OF COMMERCIAL STERILITY?**     |
| ** |                                                                 |
|    | **YES \[\] NO \[\]**                                            |
|    |                                                                 |
|    | #### *There are many factors, which                             |
|    |  can affect the attainment of commercial sterility for acidifie |
|    | d foods. For example, a change in the formulation such as size  |
|    | of solid pieces, the solid to liquid ratio or the type and/or q |
|    | uantity of acid used could affect the finished equilibrium pH.* |
+----+-----------------------------------------------------------------+
| *  | #### PROCESS DELIVERY                                           |
| *9 |                                                                 |
| ** |                                                                 |
+----+-----------------------------------------------------------------+
| *  | #### ARE RAW P                                                  |
| *1 | RODUCT MATERIALS PREPARED ACCORDING TO THE METHOD (GRADING, WAS |
| 0a | HING, HYDRATING, BLANCHING), ETC. AND/OR FORMULATION SPECIFIED  |
| ** | IN THE RECOMMENDED SCHEDULED PROCESS? YES \[\] NO \[\] N/A \[\] |
|    |                                                                 |
|    | ## DESCRIBE THE FIRM'S PROCEDURE                                |
|    | S FOR HANDLING/PREPARING RAW MATERIALS AND PRODUCT PREPARATION: |
+----+-----------------------------------------------------------------+
| *  | #### *There are several                                         |
| *1 | methods used to acidify low-acid foods including: Blanching in  |
| 0b | acid solutions, Immersion of blanched foods in acid solutions,  |
| ** | Direct batch acidification, Addition of acid directly to indivi |
|    | dual containers, and addition of acid foods to low-acid foods.* |
|    |                                                                 |
|    | ####                                                            |
|    |                                                                 |
|    | #### ARE P                                                      |
|    | RODUCTS ACIDIFIED ACCORDING TO THE METHOD AND/OR FORMULATION SP |
|    | ECIFIED IN THE RECOMMENDED SCHEDULED PROCESS? YES \[\] NO \[\]  |
|    |                                                                 |
|    | ## DESCRIBE THE FIRM'S PROCEDURES FOR ACIDIFICATION:            |
+----+-----------------------------------------------------------------+
| ** | #### DOES THE FIRM ADEQUATELY CONTROL pH TO ENSURE THAT T       |
| 11 | HE EQUILIBRIUM pH OF FINISHED PRODUCTS DOES NOT EXCEED THE MAXI |
| ** | MUM 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 MO                                                   |
|    | NITORING 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 i |
|    | s used, it should be accurate, adequately equipped and standard |
|    | ized to ensure it's accuracy. proper procedures should be follo |
|    | wed in operation of the pH meter as provided by the instrument  |
|    | manufacturer and specified in part 114.90 (114.90(a),110.40(f)) |
+----+-----------------------------------------------------------------+
| ** | **LIST ALL FACTORS CRITICAL TO THE ATTAINMENT OF COMMERCIAL     |
| 12 | 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):***                                                        |
|    |                                                                 |
|    | **PRODUCT CONTAINER TYPE/SIZE CRITICAL FACTOR CRITICAL LIMIT**  |
|    |                                                                 |
|    | **MAX pH**                                                      |
|    |                                                                 |
|    | **MIN. PROCESS TIME**                                           |
|    |                                                                 |
|    | **MIN. PROCESS TEMP**                                           |
|    |                                                                 |
|    | **LIST OTHER CRITICAL FACTORS:**                                |
+----+-----------------------------------------------------------------+
| ** | **OBSERVE THE PRODUCTION OF A BATCH OF ACIDIFIED FOOD PRODUCT.  |
| 13 | 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 \[\]**             |
+----+-----------------------------------------------------------------+
| *  | ***114.80 (a) (1) requires acidified foods to be thermally      |
| *1 | processed to destroy the vegetative cells of microorganism of   |
| 4a | 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**.                          |
+----+-----------------------------------------------------------------+
| *  | **DOES THE FIRM USE PRESERVATIVES TO PREVENT THE GROWTH OF      |
| *1 | MICROORGANISMS OF NON-HEALTH SIGNIFICANCE? YES \[\] NO \[\]**   |
| 4b |                                                                 |
| ** | **ARE THESE PRESERVATIVES USED IN ACCORDANCE WITH FDA FOOD      |
|    | ADDITIVE REGULATIONS?**                                         |
|    |                                                                 |
|    | **YES \[\] NO \[\]**                                            |
|    |                                                                 |
|    | **LIST THE PRESERVATIVES AND LEVELS OF USE.**                   |
+----+-----------------------------------------------------------------+
| ** | **WERE ANY PROCESS DEVIATIONS NOTED DURING THE INSPECTION? YES  |
| 15 | \[\] NO \[\]**                                                  |
| ** |                                                                 |
|    | **IF SO, WERE THE DEVIATIONS PROPERLY HANDLED? YES \[\] NO      |
|    | \[\]**                                                          |
|    |                                                                 |
|    | **114.89**                                                      |
+----+-----------------------------------------------------------------+
| ** | **ARE CRITICAL FACTORS MEASURED USING ACCURATE INSTRUMENTS? YES |
| 16 | \[\] 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))***                                          |
+----+-----------------------------------------------------------------+
| ** | #### DOCUMENTATION OF PROCESS DELIVERY                          |
| 17 |                                                                 |
| ** |                                                                 |
+----+-----------------------------------------------------------------+
| ** | **DO PROCESSING AND PRODUCTION RECORDS INCLUDE FINISHED PRODUCT |
| 18 | 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 \[\]**                                            |
+----+-----------------------------------------------------------------+
| ** | **IF AVAILABLE, REVIEW A SELECT NUMBER OF PROCESSING RECORDS    |
| 19 | (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 "REMARKS" BELOW. REPORT THE TYPE AND DATES |
|    | OF RECORDS REVIEWED.**                                          |
+----+-----------------------------------------------------------------+
| ** | **CONTAINER INTEGRITY**                                         |
| 20 |                                                                 |
| ** |                                                                 |
+----+-----------------------------------------------------------------+
| ** | **DOES TESTING AND EXAMINATION OF CONTAINERS OCCUR OFTEN ENOUGH |
| 21 | 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.***                                                  |
+----+-----------------------------------------------------------------+
| ** | **ARE CONTAINER HANDLING PROCEDURES AND CONVEYANCE EQUIPMENT    |
| 22 | ADEQUATE TO PROTECT THE CONTAINER BODY AND SEALS FROM DAMAGE    |
| ** | THAT COULD RESULT IN LEAKAGE AND POST PROCESS CONTAMINATION?    |
|    | YES \[ \] NO \[ \]**                                            |
|    |                                                                 |
|    | **(*Lids and empty and filled/sealed containers should be       |
|    | handled with care; conveyance tracks should be clean, sanitary  |
|    | and dry*) 110.40(a); 110.80)**                                  |
+----+-----------------------------------------------------------------+
| ** | **IS EACH CONTAINER IDENTIFIED WITH A VISIBLE CODE THAT         |
| 23 | SPECIFIES THE PACKER, THE PRODUCT AND THE YEAR, DAY AND PERIOD  |
| ** | OF PACK? YES \[ \] N0 \[ \]**                                   |
|    |                                                                 |
|    | **IS THE PACKING PERIOD CODE CHANGED OFTEN ENOUGH TO ASSURE     |
|    | READY IDENTIFICATION OF LOTS DURING THEIR SALE & DISTRIBUTION?  |
|    | YES \[ \] NO \[ \]**                                            |
|    |                                                                 |
|    | ***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 INTERALS 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 114.80(b)***                           |
+----+-----------------------------------------------------------------+
| ** | **FIELD EXAMINE INDIVIDUAL CONTAINERS OF ANY SUSPECT PRODUCT    |
| 24 | 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.**                                         |
+----+-----------------------------------------------------------------+
| ** | ##                                                              |
| 25 | ## DOES THE FIRM HAVE A RECALL PLAN ON FILE? YES \[ \] NO \[ \] |
| ** |                                                                 |
|    | **108.25(e).**                                                  |
|    |                                                                 |
|    | ######## DOES THE                                               |
|    |  FIRMS RECORDS IDENTITY INITIAL DISTRIBUTION OF LOTS OF PRODUCT |
|    |                                                                 |
|    | **114.100 (d)** **YES \[ \] NO \[ \]**                          |
+----+-----------------------------------------------------------------+
| ** | #### HAVE APPROPRIATE P                                         |
| 26 | LANT PERSONNEL ATTENDED AND COMPLETED A SCHOOL APPROVED BY FDA? |
| ** |                                                                 |
|    | ####  YES \[ \] NO \[ \]                                        |
|    |                                                                 |
|    | **108.25(f)**                                                   |
+----+-----------------------------------------------------------------+
| ** | #### OBJECTIONABLE CONDITIONS/DISCUSSION WITH MANAGEMENT        |
| 27 |                                                                 |
| ** |                                                                 |
+----+-----------------------------------------------------------------+
| ** | #### SAMPLES COLLECTED                                          |
| 28 |                                                                 |
| ** |                                                                 |
+----+-----------------------------------------------------------------+
| ** | #### EXHIBITS                                                   |
| 29 |                                                                 |
| ** |                                                                 |
+----+-----------------------------------------------------------------+