Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
NOV 24, 2014
VIA EXPRESS DELIVERY
Mr. Vo Quang Vinh, Deputy Director
Cau Tre Export Goods Processing Joint
125/208 Luong The Vinh Street
Tan Thoi Hoa Ward
Ho Chi Minh City, Vietnam
Reference # 422600
Dear Mr. Vinh:
This letter is in response to the information and documentation your firm provided on May 9, 2014, in response to observations of concern noted during an inspection by the U.S. Food and Drug Administration (FDA) of your seafood processing facility, Cau Tre Export Goods Processing Joint located at 125/208 Luong The Vinh Street, Tan Thoi Hoa Ward, Ho Chi Minh City, Vietnam, which was conducted on April 14-15, 2014. During that inspection, 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.
This response included descriptions of your corrective measures, revised HACCP plans for your frozen shrimp dumplings, snow crab with garlic butter, frozen shrimp hacao/shrimp shaomai and frozen shrimp wonton soup products, as well as additional supporting documentation. We have evaluated the documentation and found that you have continuing serious deviations 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 frozen shrimp dumplings, snow crab with garlic butter, frozen shrimp hacao/shrimp shaomai and frozen shrimp wonton soup 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: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
Your significant deviations are as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits, 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 revised HACCP plans for frozen shrimp dumplings, snow crab with garlic butter, frozen shrimp hacao/shrimp shaomai and frozen shrimp wonton soup provided with your May 9, 2014, response each list critical limits as “cooking temperature (b)(4),” “cooking time,” and “Quantity of product” at the cooking critical control point which are not adequate to control pathogen survival through the cooking process because there are no specific corresponding critical limit values listed in the plan. FDA recommends that in addition to the cooking temperature, your plan should include other parameters that affect the cooking process, specifically the minimum cooking time for each type of product, as well for example, maximum batch size, and portion size(e.g. for each dumpling, wonton, etc.) to ensure that each piece receives an adequate scheduled cook process.
Further, your firm’s revised HACCP plans for frozen shrimp dumplings, frozen shrimp hacao/shrimp and frozen shrimp wonton soup list critical limits at the “Receiving Catch Shrimp” critical control point that are not adequate to control the hazard of sulfites. The listed critical limits for sulfites states, “Raw material must be harvested from areas where were checked periodically and heavy metal residues is within the allowed limit.” However, FDA is aware that sulfites are added after capture either by the fisherman or by subsequent processors. Consequently, FDA recommends raw material testing at receipt or obtaining and reviewing supplier certifications attesting to receipt of untreated shrimp in order to control sulfites.
2. You must have a HACCP plan, that at a minimum, lists monitoring procedures and their frequency, to comply with 21 CFR 123.6(c)(4). However, your revised HACCP plans for frozen shrimp dumplings, snow crab with garlic butter, frozen shrimp hacao/shaomai and frozen shrimp wonton soup provided with your May 9, 2014, response each list monitoring procedures and frequencies at the cooking critical control point that are not adequate to control pathogen growth. Specifically, your plans list “temperature of cooker with thermometer, every batch” and “cooking time with stop watch or timer every batch.” FDA recommends that your firm use a continuous temperature recording device, installed where it measures the coldest temperature of the cooking equipment with visual check every batch and a visual observation of the start and end time of each cooking cycle every batch.
You should respond in writing within fifteen (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 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 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.
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, 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 Ms. Purnell via email at email@example.com.
William A. Correll, Jr
Office of Compliance
Center for Food Safety
and Applied Nutrition