Inspections, Compliance, Enforcement, and Criminal Investigations
Pioneer Frozen Foods, Inc 1/2/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
January 2, 2013
Dale W. Tremblay, President
Pioneer Frozen Foods, Inc.
San Antonio, TX 78215
Dear Mr. Tremblay:
The Food and Drug Administration (FDA) inspected your processing facility located at 627 Big Stone Gap Road, Duncanville, Texas, from July 11 through July 20, 2012. FDA investigators documented serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulation (CGMP), Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).
Based on your failure to comply with the requirements of the CGMP regulation in 21 CFR 110, we have determined that your food products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You may find the Act and associated regulations through links on FDA’s home page at www.fda.gov.
The investigators’ observations were presented to you on an FDA-483 at the conclusion of our inspection on July 20, 2012. The significant violations documented during the inspection include:
1) Failure to treat and maintain batters to protect against contamination and growth of microorganisms, 21 CFR 110.80(b)(12).
a) During the inspection your management stated that you process pancake batter on (b)(4) lines without temperature control for up to (b)(4) hours at a time. Our investigators observed that during production, batter is (b)(4), which, according to management, remains approximately (b)(4) full at all times. Batter and/or batter residue also clings to other pancake batter processing equipment, including mixers, mixing bowls, (b)(4), and the (b)(4) leading from the (b)(4). During the inspection our investigators found the temperature of the in-process batter to be from (b)(4) to (b)(4) at various points in the process, including in the mixing bowls and at the (b)(4).
Time and temperature abuse of batter being processed for extended periods of time without temperature control, with batter temperatures above (b)(4) and as high as (b)(4) as found during the inspection, could result in pathogen, particularly S. aureus, growth and toxin production. S. aureus toxin is highly heat-stable, and once formed, will not be removed by the subsequent baking or reheating of the pancakes.
b) On July 11 and 12, 2012, our investigators observed that wheeled mixing bowls of batter are moved about the production areas on wet floors. The investigators observed that when these bowls of batter are (b)(4) to the (b)(4) and (b)(4), an unknown liquid from the wheels of the bowls flowed down the side of the bowls and dripped onto the lip of the (b)(4).
We acknowledge receipt of a letter from your Quality Assurance Manager in response to the FDA 483, dated August 5, 2012. The response states that your firm has scheduled a food safety specialist to review and validate your batter handling procedures, and that a final recommendation would be provided by September 10, 2012. However, as of the date of this letter we have not received the results of the review or the recommendation.
The response also states that you have installed a lip on the bottom of the bowls to prevent water from dripping onto the (b)(4). We will evaluate the adequacy of this corrective action during our next inspection.
2) Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary, 21 CFR 110.35(d)(2).
Specifically, during the inspection your management informed our investigators that your batter processing equipment, including mixers, mixing bowls, (b)(4), and related equipment, are used continuously without cleaning for up to (b)(4) hours at a time.
Also, the investigators observed that when one of the pancake lines is taken out of service for the (b)(4) hour cleaning, only (b)(4) of the (b)(4) mixing bowls are removed from service for cleaning at that time, and the remaining (b)(4) bowls stay in service while the second line is processing. Your employees told the investigators that they do not track which bowls have been taken out of service for the (b)(4) hour cleaning, or if all (b)(4) bowls eventually receive the (b)(4) hour cleaning.
Your August 5, 2012, response letter does not address the failure to clean equipment such as (b)(4), mixers, and (b)(4) with adequate frequency. The response states that you will now document when each of the mixing bowls are cleaned; however, the response does not address the failure to clean the bowls with adequate frequency.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Ms. Essaryat (214)253-5335.
Reynaldo R. Rodriguez, Jr.
Timothy R. Beeson, Director of Operations
Pioneer Frozen Foods, Inc.
627 Big Stone Gap Rd.
Duncanville, TX 75137