DEPARTMENT OF HEALTH & HUMAN SERVICES
March 9, 2012
VIA OVERNIGHT DELIVERY
Mr. Nguyen Thi Thu Sac, President
Hai Nam Co., Ltd.
55 Pham Ngoc Thach Street, District 3
Ho Chi Minh City, Vietnam
Reference No. 271436
Dear Mr. Nguyen Thi Thu Sac:
On September 28 – 29, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood manufacturing facility, Hai Nam Co., Ltd, located at 27 Nguyen Thong St, Phu Hai Ward, Phan Thiet City, Vietnam. We found that you have serious deviations from 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 deviations found at your firm.
We acknowledge receipt of your response provided via email on October 20, 2011 that included a revised HACCP plan as well as additional supporting documentation. Review of the response revealed continuing concerns with your seafood HACCP program, as further described in this letter.
Failure of a processor to have and implement a HACCP plan that complies with 21 CFR 123.6(g), or otherwise in accordance with the requirements of 21 CFR part 123, renders the 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 firm’s Mahi-Mahi appears to be adulterated, in that the products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
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). However, your firm’s HACCP plan for mahi-mahi, which is identified as “HACCP Plan Form” and which was provided in your response, is not adequate for the following reasons:
Your HACCP plan for mahi-mahi does not list critical limits at the “Receiving Raw Material” critical control point as follows:
Sensory evaluation: your plan does not include the number of fish to be tested. FDA recommends testing a minimum 118 fish, collected representatively throughout each lot (or the entire lot when there are fewer than 118 fish in the lot). This means that in order to meet your critical limit of 2.5% decomposition in the lot, your firm will accept the lot when no more than 2 fish in a sample of 118 show signs of decomposition.
Temperature monitoring: your plan does not include the number of fish to be sampled for temperatures at receipt. FDA recommends measuring a minimum of 12 fish, unless there are fewer than 12 fish in the lot in which case all of the fish should be monitored. Additionally, FDA recommends that firms measure the internal temperature of the largest fish in each lot, concentrating on any that show signs of having been mishandled (e.g., inadequately iced).
Your HACCP plan for mahi-mahi lists inadequate critical limits at the “Creation of C.botulinum when defrosting by end user” critical control point to control Clostridium botulinum toxin formation. FDA recommends that all finished product label include instructions to “keep frozen” and a statement such as “Important thaw under refrigeration immediately before use.”
- Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for Mahi-Mahi at the Receiving Raw Material, Pre-Processing and Processing CCPs to control histamine are not appropriate.
Your corrective actions, b(4) and ;b(4) are not adequate. In addition to listing histamine testing, FDA recommends that you also specify how many fish you will test. Currently, FDA recommends when histamine testing is performed as a corrective action, a minimum of 60 fish collected from throughout each affected lot should be sampled, and to destroy the lot or divert it to a non-food use if any fish is found with histamine greater than or equal to 50 ppm. In addition, FDA recommends discontinuing the use of a supplier if a single lot is found objectionable until evidence is obtained that the identified harvesting onboard practices and controls have been approved.
Please respond in writing within thirty (30) working days from your receipt of this letter. Your response should include documentation, such as a copy of any revised HACCP plans and at least five (5) product days worth of monitoring records 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.
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the current Good Manufacturing Practice regulations (21 CFR Part 11 0). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulation.
Please send your reply to the Food and Drug Administration, Attention: Maria Lau, CFSAN Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Maria.Lau@fda.hhs.gov. You may also contact Maria Lau at (240) 402-2271 or email if you have any questions about this letter.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition