Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
NOV 24, 2014
VIA EXPRESS MAIL
Mr. Juan Jose Aguayo Arguello, General Manager
Crimasa Criaderos De Mariscos S.A.
Medardo Angel Silva y Panama
Reference No: 442421
Dear Mr. Arguello:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, Crimasa Criaderos De Mariscos S.A. located at Medardo Angel Silva y Panama, Duran, Ecuador, on June 5- 6, 2014. During that inspection, we found that your firm had serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection listing the deviations found at your firm. We acknowledge receipt of your response to the FDA-483 received on June 27, 2014. While your response referenced corrections to the FDA-483, your response did not include a revised HACCP plan for your raw aquacultured shrimp products. Our review revealed that the responses were not adequate, as further described in this letter.
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 raw aquacultured raw shell-on shrimp products 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 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance: (the Hazards Guide) through links in FDA’s home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
Based on our review of the inspectional findings and the response documents, we find that you have the following serious deviations:
- 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 aquacultured, shell-on shrimp does not list the food safety hazard of aquaculture drugs for shrimp received from farms. Your firm receives farm raised, shell-on/ head on shrimp from aquaculture farms. However, your HACCP plan does not identify or include a control strategy to prevent distribution of shrimp to the United States that have been treated with aquaculture drugs that are unapproved for use in the United States.
- 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 aquacultured, shell-on shrimp collected during the inspection lists a monitoring procedure frequency of once per “…batch of delivery” at the “Packing” critical control point that is not adequate to control the food safety hazard of undeclared sulfiting agent because it does not ensure that each individual package used during production includes the sulfite declaration.
When using a finished product labeling control strategy for sulfite declaration, FDA recommends a monitoring frequency for review of one label at the beginning of production of each lot, container, or roll, and one label every hour thereafter.
- Corrective action plans when included in HACCP plans must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan listed in your HACCP plan for aquacultured, shell-on shrimp at the Packing critical control point to control undeclared sulfiting agents is not adequate. Your corrective actions to reject and return the batch do not correct the cause of the critical limit deviation. Your corrective action should include how your firm corrects the cause of the critical limit deviation.
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. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA’s web site at www.accessdata.fda.gov/cms_ia/ialist.html
Additionally, 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 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 foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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 consider providing a copy of this letter to your U.S. Agent.
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 regulations (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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Leslie Hintz, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Hintz at (240)402-2073 or via email at Leslie.Hintz@fda.hhs.gov.
William A. Correll, Jr
Office of Compliance
Center for Food Safety
and Applied Nutrition