- Royal Foods
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
5100 Paint Branch ParkwayCollege Park, MD 20742
March 11, 2014
VIA EXPRESS DELIVERY
Royal Foods Co. Ltd.
1547/22-26 New Petchburi Rd.
Makkasan, Bangkok 10400, Thailand
Reference No. # 420009
Dear Mr. Eiamsumang:
We inspected your seafood processing facility Royal Foods Co. Ltd.locatedat 94/20 Sestakit 1 Road, Samutsakorn, Thailand,on September 19-20, 2013. During that inspection, we found 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, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm.
We acknowledge receipt of your response sent via email on October 15, 2013. Although your response included various documents, including a written statement of corrections, a HACCP plan, and records, it was inadequate in correcting the observations of concern noted on the FDA-483, 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 mackerel in soybean paste, soy sauce, brine, soybean paste (sesame paste), and soy sauce (ginger juice) are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
Your significant deviations are as follows:
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 mackerel entitled “(b)(4),” provided with your October 15 response does not list a critical control point or multiple critical control points during the processing operations for your mackerel to control the food safety hazard of scombrotoxin (histamine) formation.
The process flow diagram provided with your October 15 response includes a number of steps prior to the start of retorting. These steps include (b)(4). Your firm indicated that (b)(4) is conducted for (b)(4). Cumulative exposure times to ambient unrefrigerated temperatures create a potential for histamine formation as a result of time and temperature abuse of the fish. Consequently, all unrefrigerated steps and extensive hold times from (b)(4) through the sterilization processing steps need to be assessed, and controls need to be in place to ensure that products are not time or temperature abused. FDA recommends that fish that have been previously frozen should not be exposed to ambient temperatures above 40°F (4.4°C) for more than 24 hours cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1°C).
2. 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. (b)(4) provided with your October 15 response, does not identify the food safety hazard of undeclared major food allergens; for example, fish protein and the soy ingredients.
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 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
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: Sheena Crutchfield, 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. Sheena Crutchfield via email at firstname.lastname@example.org.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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