- Evangel International Foods
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
September 22, 2014
Charles U. Ike, Owner and Director
Evangel International Foods, Inc.
2727 Westside Drive
Pasadena, TX 77502
Dear Mr. Ike:
We inspected your seafood processing facility, located at 2727 Westside Drive, Pasadena, TX, on April 28, 2014 through May 9, 2014. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly, your dried catfish products are adulterated, in that they been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point (CCP) is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for dried fish does not list the CCPs of your cooking and drying steps for controlling the food safety hazard of pathogens.
The inspection revealed that you manufacture dried fish which you label either “keep refrigerated” or “keep frozen.” You first cook the fish in a (b)(4) oven and then move the fish to (b)(4) dryers where the fish dries for an additional (b)(4). The fish has the appearance of a fully cooked product. However, you have no CCPs for controlling, and achieving a six-log reduction in pathogens at these steps.
Please be advised that you should determine which of your process factors have an effect on the rate of process heating and drying, and include these critical factors in your heating and drying steps as critical limits. These factors may include, but are not limited to, oven and dryer temperature and heat distribution, load, and (b)(4).
We acknowledge receipt of your May 28, 2014, letter sent in response to the FDA 483, in which you state that you have hired a consultant to assist you with a temperature study of your ovens and to revise your HACCP plans, which will take six months to complete. However, you have not explained what you will do to control pathogens in your products at these processing steps in the interim.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for dried fish lists monitoring procedures and/or frequency at the raw fish cutting and finished product labeling CCPs that are not adequate to control the hazards of metal inclusion and undeclared food allergens.
a. At the raw fish cutting CCP, your monitoring procedure is to check the condition of the saw blade (b)(4). However, we recommend that the condition of the blade be checked before start-up, every four hours of operation, at the end of the day, and after any equipment jams that may occur.
b. At the finished product labeling CCP, your monitoring procedure is to perform a visual check of the labels (b)(4). However, we recommend that you check the labels at the beginning of production and every hour thereafter.
3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the labeling CCP for label declaration of allergens or storage temperature requirements, to control the hazards of undeclared allergens and pathogens, respectively.
4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for dried fish at the raw fish cutting CCP to control the hazard of metal inclusion is not appropriate because your corrective action plan does not address the cause of the deviation.
5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor prevention of cross-contamination from insanitary objects, protection of food, food packaging material, and food contact surfaces from adulteration, and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. During the inspection, the raw fish processing was being conducted adjacent to finished product processing, and water spray from raw fish washing was observed to splash onto an employee who was handling finished dried fish.
b. During the inspection, your employees were observed to use a crowbar to separate frozen raw fish, and to pick up frozen fish that had fallen on the floor and place them into a bin with other fish to be processed.
c. Water and blood from raw fish processing was pooling on the floor of the production room where unpackaged, finished, dried fish were exposed and being processed. Fly-type insects were observed in the water.
Your response letter states that you have divided the processing room into three sections, one room for fresh fish thawing and cutting, a second room for packaging finished products, and a central area for “fresh products only.” You have not provided sufficient detail for our review, such as an explanation of the flow of operations, a floor plan, or photographs of these changes, and we are therefore unable to evaluate this corrective action.
6. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for monitoring and corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests, required for the processing of cooked and dried fish, since you began fish processing in October 2013.
We have the following additional comments regarding the HACCP documentation that was collected during our inspection:
1. The HACCP plan for dried fish that you currently use and provided to our investigators, titled “Dried Fish – Frozen,” has CCPs and/or critical limits that are “optional” or that you have elected to not implement. Specifically, you have not implemented the CCPs of “Ingredient Prep & Storage,” “(b)(4),” “Smoking & Drying” (to achieve the critical limit of a final dried fish water activity of less than 0.85), and the “proper packaging to prevent rehydration” portion of the critical limit of the “Weigh, Packing and Labeling” CCP. Some of these HACCP plan elements appear to have been designed for a shelf-stable product and/or a product packaged in reduced-oxygen packaging; however, your dried fish is not shelf stable and is not packaged in reduced-oxygen packaging.
In accordance with 21 CFR 123.6(b)(2), a HACCP plan shall be specific to each kind of fish and fishery product. The plan may group kinds of fish and fishery products together, or group kinds of production methods together, if the food safety hazards, CCPs, critical limits, and procedures required to be identified and performed in your HACCP plan are identical for all fish and fishery products so grouped, or for all production methods so grouped. We recommend that your HACCP plan for dried fish list CCPs, critical limits and monitoring procedures that are reflective of your operation and appropriate to control your specified product’s identified hazards.
2. Although you freeze all of the finished dried fish after packaging, even the fish labeled as “keep refrigerated,” you also provided HACCP plans for shelf-stable and refrigerated dried fish to our investigators, with the explanation that although you have these plans, you do not produce these products or use these HACCP plans. Please be advised that as written, these two HACCP plans do not appear to be adequate to control the potential hazards in either shelf-stable or refrigerated products. We acknowledge that your May 28, 2014 letter states that you will label all fish with “keep frozen” labels. However, we recommend that if you elect to produce refrigerated or shelf-stable products in the future, you conduct a hazard analysis, determine critical factors for your process, and develop HACCP plans that are reflective of your operation and adequate to control the identified hazards.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
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, the seafood HACCP regulation (21 CFR Part 123) 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.
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 send your reply to the Food and Drug Administration, Attention: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in this letter, please contact Seri Essary at (214) 253-5335.
Reynaldo R. Rodriguez, Jr.
Dallas District Director