Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Dallas District Office
4040 North Central Expressway
Dallas, Texas 75204-3128
June 26, 2015
UPS OVERNIGHT MAIL
Richard L. Clements, Owner and CEO
Clements Foods Company
6601 N. Harvey Place
Oklahoma City, OK 73116
Dear Mr. Clements:
On February 4 to 13, 2015, an investigator of the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 6601 N. Harvey Place, Oklahoma City, OK 73116, where you manufacture a variety of acidified foods. During that inspection, we found that you had 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)). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. We received your firm's response to the FDA-483 dated February 13, 2015, which includes a letter with descriptions of your corrective actions. Our review of the documentation determined that the response was not adequate, as further described in this letter. 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.
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, 21 CFR Part 114, Acidified Foods, and 21 CFR Part 110 current Good Manufacturing Practices. 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. You can find the Act and the Acidified Food regulations through links in FDA's home page at http://www.fda.gov.
Your significant violations are as follows:
1. As a commercial processor in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Specifically, your firm failed to file scheduled processes with FDA for the (b)(4) Syrup and the (b)(4) Syrup. Your firm uses these scheduled processes to manufacture the acidified foods.
Your February 13, 2015, response indicated that your firm will file the missing scheduled processes. However, you have not provided a timeframe for completion and the details of when your firm will submit the syrup formulations and process specifications to FDA.
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: http://www.fda.gov/Food/FoodSafety/ProductSpecificlnformation/AcidifiedLowAcidCannedFoods/default.htm.
For additional information on the types of products FDA considers to be acidified, please refer to the 2010 Draft Acidified Food Guidance Document at the following link: http://www.fda.gov/Food/GuidanceComplianceRegulatorylnformation/GuidanceDocuments/AcidifiedandLow-AcidCannedFoods/ucm222618.htm.
2. Your firm failed to have your scheduled processes established by a qualified person who has expert knowledge acquired through appropriate training and experience in manufacturing of acidified foods, as required by 21 CFR 114.83. Specifically, the scheduled process for (b)(4) Syrup and (b)(4) Syrup were not established or evaluated by a process authority.
Your February 13, 2015, response is inadequate because it does not provide any details as to when your firm will submit the syrup formulations and process specifications to a process authority for evaluation.
3. Your firm failed to process each acidified food in conformity with at least the scheduled process, as required by 21 CFR 108.25(c)(3)(i). Specifically your firm's filed scheduled process for (b)(4) Syrup, (b)(4) oz container, (SID # (b)(4)), identifies (b)(4) acid as the acidifying agent under "Acidified or Controlled Factors." However, your firm adjusted the pH of three batches of (b)(4) by adding an additional acidifying agent, (b)(4) acid, to the existing (b)(4) acid identified on the scheduled process.
According to our investigator's review of your processing records:
• 6 oz of (b)(4) acid were added to Batch #1 on 5/15/14, container code #(b)(4).
• 4 oz of (b)(4) acid were added to Batch #1 on 7/24/14, container code #(b)(4).
• 6 oz of (b)(4) acid were added to Batch #4 on 10/01/14, container code #(b)(4).
Your February 13, 2015, response stated that your firm ceased using (b)(4) acid to adjust the pH in any products that do not list it as an ingredient on the product label. However, you failed to provide an explanation of how you intend to maintain pH control for future batches of (b)(4).
4. Your firm failed to construct or maintain the plant in such a manner as to prevent drip and condensate from contaminating food and food contact surfaces, as required by 21 CFR 110.20(b)(4). Specifically, our investigator observed water condensate drops at the bottoms of the overhead piping in the Dressing Production Room. Water droplets could drop onto the conveyor rack that carries the food containers (lids).
Your February 13, 2015, response stated that your firm plans to insulate the refrigerated pipes and install additional line covers to eliminate condensate drips over your products. Your response is inadequate because you failed to specify a timeframe for completion, a plan for conducting routine visual inspections to ensure that the condensate drips have been eliminated, and did not provide photographs.
In addition, we reviewed the process authority documents and your firm's Form FDA 2541a for SID (b)(4). According to the "Process Authority's Product Evaluation" form for the (b)(4) Syrup, the critical limits were (b)(4)°F for (b)(4) minutes with a maximum equilibrium pH of (b)(4). Your firm's Form FDA 2541a for SID (b)(4) identified a maximum pH of (b)(4). Please ensure the filing is correct for this product and re-submit your scheduled process accordingly. In addition, please provide information as to how the underside of your caps is sterilized in the filing comments section when you re-file your scheduled processes.
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 Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Mr. Ta at (214)-253-5217.
Reynaldo R. Rodriguez, Jr.
Dallas District Director