- S & S Foods, Inc.
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District Office|
4040 North Central Expressway
Dallas, Texas 75204
April 26, 2016
Erick E. Womack, President and Owner
S & S Foods, Inc.
1209 E. Highline Lane
Mustang, Oklahoma 73064-6406
Dear Mr. Womack:
Between the dates of October 20, 2015 to November 9, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1209 E. Highline Lane, Mustang, Oklahoma 73064; where you contract manufacture a variety 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), Part 114, Acidified Foods (21 CFR Part 114) and Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR Part 110). 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 it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find the Act and the Acidified Food regulations through the link 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 related 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 Part 114.
During our inspection, we observed the following significant violations:
1. As a commercial processor engaged in the thermal processing of acidified foods you must, (b)(3)(A) 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). The FDA has no acidified scheduled process on file (b)(3)(A) for your product, (b)(4).
Further, your firm could not provide evidence that the scheduled processes for the acidified food products that you manufacture were established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods, as required by 21 CFR 114.83. Specifically, your firm is using a hot-fill and hold process to manufacturer your product, (b)(4), that has not been evaluated by your Process Authority.
In your November 27, 2015 written response, you state that you are in the process of obtaining “process authority letters” for all of your acidified products, including (b)(4), and will file them with the FDA as they become available. As of the date of this letter, you have not filed a scheduled process with the FDA for (b)(4). If you have fully implemented this correction, please provide documentation of such in your response to this letter.
2. 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 process filed with FDA for (b)(4) calls for hot-fill temperature of (b)(4)°F with a (b)(4) minute hold time, and your process filed with FDA for (b)(4) with (b)(4) calls for hot-fill temperature of (b)(4)°F with an (b)(4) minute hold time. However, on October 30, 2015, you processed your (b)(4) and (b)(4) with a hot-fill temperature between (b)(4)°F with a (b)(4) minute hold time.
Furthermore, you have Process Authority letters dated September 5, 2013, recommending scheduled processes for (b)(4) and (b)(4) which respectively call for the minimum product temperature and hold time combinations as follows: (b)(4) and (b)(4). Based on your observed process, you are not following either the scheduled process filed with the FDA or the process recommended by the Process Authority.
In your written response, you acknowledge that you do not manufacture “most” of your acidified products according to the scheduled processes established by a Process Authority. Your response further states that you are having all of your products reevaluated by your Process Authority, and will file them as they become available. You did not provide a timeframe for completion for reevaluation of your acidified products, nor did you explain your firm’s production plans for these products pending the process reevaluation. If you have fully implemented this correction, please provide documentation of such in your response to this letter.
3. You failed to exercise sufficient control including frequent testing and recording of results so that finished equilibrium pH values are not higher than 4.6, as required by 21 CFR 114.80(a)(2). During our inspection your firm did not conduct finished product equilibrium pH testing for any of your acidified food products. Furthermore, your production records for acidified products you produced since 2013 were either not kept or did not include records of finished product equilibrium pH testing for any of your acidified food products.
The production records you provided covered acidified food products produced after December 10, 2014. These records included documentation of in-process pH measurements, which you explained were measured while the products are still hot from processing. Note that 21 CFR 114.90(a)(3)(ii) states that in order to obtain accurate results without a temperature compensator, pH measurements with electrodes should be made between 20-30°C (68-86°F).
In your written response, you indicated that your firm is now measuring the equilibrium pH of your acidified food products and recording such in your production logs. Your response also stated that you no longer measure in-process pH of your acidified food products. In addition to testing and recording finished equilibrium pH of your acidified food products, FDA recommends that you continue to monitor the in-process pH at an appropriate temperature, as a means to control your process. Your response cannot be evaluated because of a lack of supporting documentation in that you did not include copies of production records which would allow us to evaluate your corrective actions. If you have fully implemented this correction, please provide documentation of such in your response to this letter.
4. You failed to maintain processing records showing adherence to the scheduled process, including records of critical factors, as required by 21 CFR 114.100(b). Specifically, your firm does not maintain processing records, which document the critical factors in your acidified food processes such as, finished equilibrium pH, process temperature, process time, temperature of the product at the end of the hold time, and inverted container hold time.
Your production records for the production dates ranging from April 1, 2013 to October 22, 2015 contained only in-process product pH records. Furthermore, you did not have any processing records for the acidified food products you produced from April 1, 2013 to December 10, 2014. You failed to record any records for any of the above listed critical factors.
We acknowledge that during our inspection you recorded the cook temperature and time, fill temperature and a check mark for “(b)(4)” on October 22, 2015 for (b)(4) and (b)(4), respectively, and added the equilibrium pH for (b)(4) on October 26, 2015. However, these recorded values demonstrate that you are not adhering to either your processes filed with the FDA or the scheduled processes recommended by your Process Authority.
In your response letter, you indicated that your firm is developing a production log sheet to document finished product equilibrium pH readings. Your response does not address how your firm will monitor and document the other factors critical to your acidified food processes, such as, temperatures and times. If you have fully implemented this correction, please provide documentation of such in your response to this letter.
5. You failed to adequately maintain instruments used for measuring, regulating, and recording conditions that control or prevent the growth of microorganisms, as required by 21 CFR 110.40(f). Specifically, your firm does not keep calibration records for your pH meter and thermometers. These instruments are used to measure the critical limits of pH and temperature in your acidified food processes. In order to ensure accurate results, the instruments should be adequately maintained which includes regular calibration. When measuring pH with a potentiometric method, the standardization of electrodes should be an integral part of the measurement procedure.
We acknowledge that in your response you indicate that you calibrate these devices regularly and will develop a written calibration schedule. If you have fully implemented this correction, please provide documentation of such in your response to this letter.
6. As a commercial processor engaged in the processing of acidified foods you must prepare and maintain files on a current procedure for use for products under the processor’s control, including plans for recalling products that may be injurious to health; for identifying, collecting, warehousing, and controlling products; and for determining the effectiveness of recalls; for notifying the FDA of any recalls; and for implementing recall programs, to comply with 21 CFR 108.25(e). However, you failed to prepare a written recall procedure.
We acknowledge that your response letter stated that you have a recall procedure for USDA products that you process, and that you will use this procedure for the FDA regulated acidified products you process. However, your response cannot be evaluated because of a lack of supporting documentation in that you did not include a copy of the recall procedure. If you have fully implemented this correction, please provide documentation of such in your response to this letter; otherwise we will verify this corrective action during the next inspection.
In addition to the above referenced violations, we also have the following comments:
During our inspection of your facility, you informed our Investigator that one of your customers returned (b)(4) jars of (b)(4) due to swollen and leaking lids. You stated that you destroyed the product with swollen and leaking lids, stored the remaining containers, and then consulted with your process authority. Based on your process authority’s advice that lactic acid bacteria was likely the cause of the spoilage and would not cause illness, you redistributed the remaining product which showed no signs of spoilage to your customer.
As cited above, your firm does not follow the scheduled processes recommended by your process authority. Furthermore, you did not have any process records of the critical factors to the process for the returned product. We note that you claimed to have voluntarily recalled all (b)(4) produced from December 2014 – May 2015. We also recognize that the samples of (b)(4) produced by your firm on September 30, 2015 and collected by our investigator during our inspection were analyzed by an FDA laboratory and found to have a pH range of (b)(4). Additionally, we note that you informed FDA in a phone conversation on January 13, 2016 that your process authority had observed your process for (b)(4) and determined that the (b)(4) were not receiving an adequate heat treatment. Although you stated that your process for this product would be modified to include (b)(4), as of the date of this letter, we have not received any changes to your scheduled process on file for (b)(4). Please provide documentation of the disposition of your recalled product as well as any process corrections you have implemented in your response to this letter.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure 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 actions 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) business 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 processes have been filed with the FDA. If you cannot complete all corrective actions within 15 days, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your reply should be sent to the Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204, Attention Paul E. Frazier, Compliance Officer. If you have questions regarding any issue in this letter, please contact Mr. Frazier at (214) 253-5340.
Reynaldo R. Rodriguez, Jr.
Dallas District Director