WARNING LETTER
Ee Hui Food Manufacture PTE Ltd
MARCS-CMS 593779 —
November 22, 2019
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Cheng Hwee Ng
Recipient Title
President
Ee Hui Food Manufacture PTE Ltd
58 Senoko Drive, Senoko Industrial Estate
Singapore, SG-NA, 758237
758237
Singapore
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740-3835
United States
WARNING LETTER
Reference# 593779
Dear Mr. Cheng Hwee Ng:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, EE HUI Food Manufacture PTE LTD located at 58 Senoko Drive, Senoko Industrial Estate, Singapore, SG-NA, 758237 on June 24 and 25, 2019. 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, the FDA investigator issued an FDA-483, lnspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response received via email on July 15, 2019. Your response included a revised hazard analysis and undated revised HACCP plan, entitled "Cooking & Frying Products," as well as HACCP monitoring records and standard operating procedures. Review of the documentation revealed that your response is not adequate, 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 frozen, ready-to-eat vacuum (RTE) packed surimi-based products, i.e. various seafood balls and cakes, 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
.
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.G(a) and (c)(l). 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 revised HACCP plan entitled "Cooking & Frying Products" does not list the food safety hazards of
Clostridium botulinum (C. botulinum)
growth and toxin formation and undeclared allergens.
C. botulinum
growth and toxin formation is reasonably likely to occur in your vacuum packaged products as this packing type creates an anaerobic condition conducive to growth and toxin formation when mishandled, particularly when products are refrigerated (i.e., not frozen). Specifically, this hazard is reasonably likely during thawing of your vacuum packaged surimi, during chilled storage of your refrigerated vacuum packaged finished products, and throughout distribution of your refrigerated vacuum packaged finished product. The hazard of undeclared allergens is reasonably likely to occur because your firm manufactures products that contain fish (threadfin bream), crustacean shellfish {shrimp), wheat, egg, dairy, and soy.
For more information on controlling the food safety hazards of C. botulinum growth and toxin formation and undeclared allergens, see Chapters 13 and 19 of the Hazards Guide.
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 revised HACCP plan entitled "Cooking & Frying Products," does not list one or more critical control points for cooling after cooking and frying to control the food safety hazard of pathogenic bacteria growth and toxin formation, as a result of post processing contamination.
3. 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). 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 plan entitled "Cooking & Frying Products";
a. Lists a critical limit of "
(b)(4)
" at the "
(b)(4)
" and "
(b)(4)
" critical control point that is not adequate to control pathogenic bacteria survival through cooking because you do not have critical limit values for cook times and temperatures as part of your HACCP plan. Specifically, you could not provide a temperature chart for the "
(b)(4)
" and "
(b)(4)
" critical control point, as referenced in your plan, to indicate time and temperature parameters adequate to control pathogenic bacteria survival through cooking were achieved. We acknowledge receipt of what appear to be monitoring records such as the "
(b)(4)
" (i.e., your "
(b)(4)
" ) and the "
(b)(4)
" (i.e., the "
(b)(4)
" critical control point monitoring record). We also note the products listed for each do not appear to be the same products listed. Once you establish adequate critical limits at the "
(b)(4)
" and "
(b)(4)
" Critical control points, FDA recommends that you monitor the temperature of the cooker and fryer using a continuous temperature recording device (for example, a recording thermometer) with continuous monitoring by the device itself and a visual check of the recorded data at least once per day. FDA also recommends that you monitor the speed of the belt using a stopwatch or tachometer to monitor the speed of the belt drive wheel at least once per day, and whenever any changes in belt speed are made.
b. Lists a critical limit of "
(b)(4)
" at the "
(b)(4)
" critical control point that is not adequate to control pathogenic bacteria growth and toxin formation. Specifically, the critical limit does not list a value for the temperature of the chiller. Once your firm establishes an appropriate critical limit at the "
(b)(4)
" critical control point, FDA recommends that you monitor the ambient air temperature of the cooler using a continuous temperature-recording device (for example, a recording thermometer) with continuous monitoring by the device itself and a visual check of the recorded data at least once per day.
4. 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 plan for frozen, vacuum packed, surimi-based products at the "
(b)(4)
" and "
(b)(4)
" critical control points to control pathogenic bacteria growth is not appropriate. In addition, to correcting the cause of the deviation, your corrective action must ensure that no adulterated product enters commerce.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as 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 believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.
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. This alert can be found on FDA's web site at:
http://www.accessdata.fda.gov/cms_ia/importalert_25.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 and the current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117 Subpart B). 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: Elizabeth A. DeGiglio Girard Compliance Officer, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Elizabeth Girard via email at Elizabeth.Girard@fda.hhs.gov. Please reference CMS# 593779 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
12/17/2019
Regulated Product(s)
Food & Beverages