Inspections, Compliance, Enforcement, and Criminal Investigations
Huwen Huang Import And Export Sa 1/31/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
JAN 31, 2014
VIA EXPRESS DELIVERY
Mr. Ningsi Huan/Owner
Huwen Huang Import and Export Sa.
Frente Al Consejo Supremo Electoral Casa
Reference No. 418360
Dear Mr. Huan:
We inspected your seafood processing facility, Huwen Huang Import and Export Sa., located at Frente Al Consejo Supremo Electoral Casa, Managua, Nicaragua, on August 23-25, 2013. During that inspection, we found that you had serious 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, FDA issued a FDA-483, Inspectional Observations, listing the observations of concern found at your firm.
We acknowledge receipt of your response, sent via email on September 6, 2013, that included written corrective measures to the FDA-483 observations. We have assessed the response and have continuing concerns as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a processor of fish and 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 (b)(4) 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 Fisheries Products Hazards and Control Guidance (the Hazard Guide) through links in FDA’s homepage 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: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm.
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 HACCP plan for (b)(4) does not list the food safety hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse and inadequate drying.
Because your products are not intended to be held refrigerated, FDA recommends that you establish proper critical limits to ensure that each batch of finished product achieves a final water activity of 0.85 or below at the end of the drying process. Further, FDA recommends that the drying process is conducted in a sufficiently short period of time to control pathogenic bacterial growth during the operation, until the products reach a water activity of 0.85 or below.
2. You must have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(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 (b)(4) does not list the following critical control points:
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 or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, 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 applicable laws and regulations. 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 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
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 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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 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 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.
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at email@example.com.
Charlotte A. Christin
Office of Compliance
Center for Food Safety
and Applied Nutrition