El Campestre Distributor 9/30/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
RETURN RECEIPT REQUESTED
September 30, 2013
Miguel A. Franco, Owner/President
El Campestre, Inc.
1400 S. Santa Fe Avenue
Compton, CA 90221
Dear Mr. Franco:
We inspected your seafood processing facility, located at 1400 S. Santa Fe Avenue, Compton, California on May 29, 31, June 5 and 10. 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 ready-to-eat seafood salads are adulterated, in that they have 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.
We acknowledge receipt of your written response dated July 17, 2013. We have reviewed your response, which included a newly developed HACCP plan, as well as corresponding records and find your response inadequate to address the violations. We have included our comments below in relation to each of the noted violations. The significant violations are as follows:
Your significant violations were as follows:
- You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for “Seafood Salads” does not list the following food safety hazards:
- Undeclared allergens for your finished products that contain allergen sub ingredients (i.e. egg, wheat, soy, fish, crab) such as your “Ceviche Mixto”.
- Undeclared sulfites in shrimp.
- Clostridium botulinum growth and toxin formation for refrigerated vacuum-packed imitation crab meat.
Please refer to Chapters 13 and 19 of the Fish and Fishery Products Hazards and Controls Guidance.
- 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 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 “Seafood Salads” does not list the critical control points of receiving, storage, and thawing, for controlling the food safety hazard(s) of “Pathogen Growth”. Specifically,
a. Your plan does not list a receiving critical control point (CCP) for the refrigerated vacuum-packed imitation crab meat you receive.
b. Your plan does not list a storage CCP for the in-process, raw material and finished fish and fishery products you store in your cooler. Also, your response states that you will monitor your walk-in cooler temperature 3 times a day. FDA recommends the use of equipment, on site, capable of continuously monitoring and recording temperatures on a 24 hour a day/7 day a week basis, with a daily check of the record and a daily check of the equipment. A monitoring frequency of 3 times a day does not provide an equivalent assurance of safety and does not account for storage of product overnight or during non-operational days (i.e. Holiday’s and weekends).
c. Your plan does not list a thawing CCP for thawing frozen vacuum-packed imitation crab meat.
Please refer to Chapter 12 of the Fish and Fishery Products Hazards and Controls Guidance for guidance on determining appropriate critical limits and monitoring procedures for receiving, storage and thawing critical control points. Your plan should identify each specific critical control point by name along with the specific corresponding hazard, critical limit, monitoring procedure, corrective action, verification procedure and record(s). We recommend you refer to Chapter 2 of the Fish and Fishery Products Hazards and Controls Guidance and Appendix 1 to assist you in revising your HACCP plan format. The regulation does not require that you use the form included in Appendix 1, however, using this standardized form may help you develop an acceptable plan and will expedite regulatory review.
- 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 the condition and cleanliness of food contact surfaces and prevention of cross-contamination from insanitary objects with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
- The (b)(4) vegetable processing machine used to cut ingredients used in your seafood salads had visible product residue after it was cleaned, sanitized and ready for use. For example:
i. Dried orange product residue was observed on the rim and exterior surface of the hopper.
ii. The dicing blade had incrusted product residue after it was washed and sanitized.
- While manufacturing ready-to-eat Ceviche Mixto an employee was observed touching several non-food contact surfaces and then touching ready-to-eat food product without washing and sanitizing his hands or changing gloves during the entire processing. For example,
i. The employee used a wet towel to wipe off the processing table and proceeded to shred imitation crab meat.
ii. The employee washed tomatoes and cilantros in the sink, then used his hands to pick up excess food particles from the sink drain, and then touched ready to eat food product.
iii. The employee reached into his pants pocket to answer their personal cell phone and then proceeded to handle ready-to-eat food product.
iv. The employee touched the processing room door and continued to handle ready-to-eat food product.
v. The employee was observed touching the trash can throughout production.
vi. The employee picked up a water hose from the floor and proceeded to handle ready-to-eat food product.
vii. The employee touched the bottom of cardboard boxes containing cilantro, imitation crab meat, and tomato.
- While cleaning, an employee was observed using a pressurized hose to rinse off the floor and water was observed to splash back onto cleaned equipment.
We acknowledge that your response states that you have trained your employees on prevention of cross contamination, however these corrections require verification during your next inspection.
- 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 safety of water which comes into contact with food or food contact surfaces, including water used to manufacture ice, 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 your ready-to-eat seafood salads for production before 2/11/13 and after 3/01/13.
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.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
- We note that your HACCP plan and response refers to regulations administered by the USDA Food Safety and Inspection Service. Specifically, your HACCP plan’s corrective action and verification columns reference 9 CFR 417. Please refer to 21 CFR 123.7 for the corrective action and 21 CFR 123.8 for the verification requirements of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
Alonza E. Cruse
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence