- Rainbow Export Processing S.A.
- Issuing Office:
- Center for Food Safety and Applied Nutrition
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
MAR 4, 2015
VIA EXPRESS DELIVERY
Mr. Rene Diers
Rainbow Export Processing S.A.
Zona Franca, Barranca
Puntarenas, Costa Rica
Reference # 447268
Dear Mr. Diers:
On August 18 and 19, 2014, we inspected your seafood processing facility, Rainbow Export Processing S.A., located at Zona Franca, Barranca, Puntarenas, Costa Rica. We found that you had violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm.
We acknowledge receipt of your response sent via email on November 11, 2014. Your response included a copy of your revised HACCP plan and Standard Operating Procedures. However, review of the documentation revealed that the response was 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 shrimp products are adulterated, in that they have been prepared, packed, or held under 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on 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:
Your significant deviations are as follows:
1. 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 revised HACCP plan for aquaculture farmed shrimp provided with your response does not list the food safety hazard of aquaculture drugs that are not approved for use on shrimp destined for the U.S. marketplace.
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). A "critical limit" is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However,
your firm's updated HACCP plan for raw aquaculture farmed shrimp provided with your response lists a critical limit "All boxes must have the label, it must include all the bisulphite info and the word shrimp" at the Packing and Labeling critical control point that is not adequate to ensure that each package of shrimp includes the declaration of the sulfites. FDA recommends that your firm monitor each batch of labels to ensure that sulfites and shrimp are declared in the ingredient statement on all of the labels.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan, 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 implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 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 take further action to 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. You may view this alert at: http://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 there-inspection and assessing and collecting there-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 deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 11 0). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at: firstname.lastname@example.org.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition