Inspections, Compliance, Enforcement, and Criminal Investigations
O'Kroft Family Foods d.b.a. Willie B's
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
May 1, 2012
Scot Cockroft, Owner
2002 Industrial Blvd.
Rockwall, Texas 75087-4907
Dear Mr. Cockroft:
On February 14 to 22, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2002 Industrial Blvd., Rockwall, Texas, where you manufacture several varieties of acidified foods. The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)). Accordingly, we have determined that your acidified 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)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through links in FDA's home page at http://www.fda.gov.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114.
During our inspection, we observed the following significant violations:
- You must maintain processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, and containing sufficient additional information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production, to comply with 21 CFR 114.100(b).
However, you failed to maintain processing and production records showing adherence to the scheduled process, including records of heat processing and other critical factors. Specifically, your firm did not measure and record the critical control measurements of heat treatment or time for at least seventy-nine (79) lots of various acidified foods manufactured by your firm in the year prior to the inspection. Further, although your scheduled process calls for (b)(4) you do not perform this procedure.
- Your firm must exercise sufficient control including frequent testing and recording of results so that the finished equilibrium pH values are no higher than 4.6, as required by 21 CFR 114.80(a)(2). However, a homogeneous mixture was not prepared to determine the final equilibrium pH of your acidified products as recommended by 21 CFR 114.90.
- Your firm must ensure that each container is marked with an identifying code specifying the establishment where the product was packed, the product contained therein, and the year, date, and period during which it was packed, as required by 21 CFR 114.80(b). However, our investigators observed that none of your lot codes contain information identifying your plant, and the part of the lot code that identifies the product was not used consistently. For example, on August 3, 2011, you manufactured (b)(4) Marinara with lot code (b)(4), with the first “2” identifying the product, and on September 28, 2011, you manufactured the same product with lot code (b)(4), with “5” identifying the product. Similarly, on April 18, 2011, you manufactured Willie B’s Original Salsa with lot code (b)(4), with “2” identifying the product, and on June 9, 2011 you manufactured the same product again with lot code (b)(4), with “1” identifying the product.
- You must have personnel involved in acidification, pH control, heat treatment and critical factors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the FDA commissioner as required by 21 CFR 108.25(f). However, our investigators observed that (b)(4) who completed the necessary training (b)(4) not present or routinely accessible during your acidified food manufacturing operations.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
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.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your written response should be sent to Seri L. Essary, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214) 253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director