Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534251.htm
Timestamp: 2019-01-18 17:53:33
Document Index: 451471974

Matched Legal Cases: ['art 123', 'art 123', '§ 342', '§ 381', '§ 379', '§ 379']

Pesquera Nivama SAC 8/30/16
Mr. Javier Pacheco Monteverde
Co-Owner I Sales Manager
Calle: os Zorzales 160, San Isidro
Reference # 500707
Dear Mr. Pacheco Monteverde:
We inspected your seafood processing facility, Pesquera Nivama SAC located at Sub Lote A S/N, Zona Industrial III Sector Tierra Colorada Paita, Piura Peru on March 10, 2016. That inspection revealed serious violations of 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, lnspectional Observations, listing the deviations found at your firm at the conclusion of the inspection.
We acknowledge receipt of your responses sent via email on on June 12, June 6 and June 3, 2016. Your responses included flow diagrams and revised HACCP plans for your cooked, frozen, ready-to-eat giant squid (cephalopods) and for your scombrotoxin (histamine) forming species of fish and photographs of your facility. We have evaluated the documentation and found that you have a continuing serious deviation of the seafood HACCP regulation, as further explained 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 cooked, frozen, ready-to-eat giant squid (cephalopods) 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: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.
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 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 revised HACCP plan for cooked, frozen, ready-to-eat giant squid (cephalopods) does not list the critical control points of cooking and cooling for controlling the food safety hazard of pathogen growth and toxin formation. (b)(4). Any processing step where a (b)(4) may occur in the absence of a control must be included in the HACCP plan. (b)(4) cannot replace the listing of controls in your HACCP plan.
ln addition, we note that the cooked cephalopods appear to be partially cooled and then are significantly handled after the cooking processed. FDA recommends that safety controls are included in HACCP plans to assure that cooked fish are quickly cooled and that exposure to unrefrigerated conditions are controlled. For example, we recommend cooling to 70 °F (21.1 °C) or below within two hours and further cooling to 40 °F (4.4 °C) or below within an additional four hours. We were unable to evaluate the adequacy of your revised HACCP plan for scombrotoxin (histamine) forming species of fish because the plan is in Spanish. Please provide a copy of this revised HACCP plan in English with your response.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan for cooked, frozen, ready-to-eat giant squid (cephalopods) products, 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. Submission of the information in English will assist in our review. 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 action to refuse admission of your seafood products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including subjecting it to 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. For your information, an example of an lmport 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/importalert_25.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 you firm operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123), the cGMP regulation (21 CFR 110), and other applicable regulations. 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 Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Sexton via email at rosemarv.sexton@fda.hhs.gov. Please reference #CMS 500707on any submissions and within the subject line of any emails to us.
Pesquera Nivama SAC - Close Out Letter 1/10/18