WARNING LETTER
TS Food Industry Sdn. Bhd. MARCS-CMS 515032 —
- Recipient:
- TS Food Industry Sdn. Bhd.
United States
- Issuing Office:
- Center for Food Safety and Applied Nutrition
United States
| |
5001 Campus Drive College Park, MD 20740 |
WARNING LETTER
FEB 28, 2017
VIA EXPRESS DELIVERY
Mr. Boon Chay Lim, Managing Director/Owner
TS Food Industry Sdn. Bhd.
No. 8 Jalan Istimewa 8,
Taman Perindustrian Cemerlang,
81800 Ulu Tiram, Johor, Malaysia
Reference # 515032
Dear Mr. Lim:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, TS Food Industry Sdn. Bhd., located at No. 8 Jalan Istimewa 8, Taman Peridustrian Cemerlang 81800 Ulu Tiram, Johor, Malaysia, on October 18 and 19, 2016. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your responses received via email on November 19, 2016 and December 15, 2016, which included documentation describing corrections to the observations of concern noted on the form FDA-483, a revised HACCP plan dated October 28, 2016, along with supporting documents. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
In accordance with 21 CFR 123.6(g), failure of a seafood processing facility 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 cooked surimi based 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.
We note the following significant deviations:
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 HACCP plan for cooked surimi based products, titled “LINE 3 PRODUCTS – FROZEN BULK PACK”, does not list critical control points for controlling the food safety hazard of pathogen growth and toxin formation for the following processing steps:
a. The thawing of air-packed surimi. Our inspection revealed that you thaw frozen pasteurized threadfin bream surimi in an (b)(4) for a maximum of (b)(4). Our investigator measured the ambient temperature of the room at 17.5°C (63.5°F). Thawing surmi products at (b)(4) for extended time periods poses a risk for pathogen growth and toxin formation, specifically Bacillus cereus (B. cereus) growth and toxin formation. Spores of B. cereus can survive typical surimi pasteurization temperatures. B. cereus produces a heat-stable toxin that is not destroyed by cooking and consequently may survive the subsequent cook temperatures. FDA recommends including a critical control point in your HACCP plan with a critical limit that lists surimi is maintained at an ambient refrigerated temperature of 4.4°C (40°F) or below for the duration of the 20 hours. Also, once you have established a critical limit, the monitoring procedure should list continuous temperature monitoring and recording with a daily check of the recorded data.
b. (b)(4) of your surimi based products. Significant handling of surimi products introduces the hazard of Staphylococcus aureus (S. aureus). Similar to B. cereus, S. aureus also produces a heat-stable toxin that is not destroyed by cooking. During our inspection, the investigator observed the (b)(4). This (b)(4) is at the maximum recommended amount for cumulative time and temperatures exposures. When product is exposed to ambient temperatures that exceed 21.1°C (70°F), the time should be 3 hours or less. FDA recommends a critical control point with a critical limit that lists the total cumulative time for unrefrigerated processing is 3 hours or less.
2. 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, in your HACCP plan for cooked surimi based products, titled “LINE 3 PRODUCTS – FROZEN BULK PACK” at the critical control point of “Cooling,” the listed critical limit of “Temperature 0-4°C” alone is not adequate to control the hazard of pathogen growth and toxin formation. FDA recommends the critical limit ensure product internal temperature cooling from 57.2 to 21.1°C (135-70°F) within 2 hours and from 21.1 to 4.4°C (70-40°F) within 4 hours, in addition to a chiller temperature of 4.4°C (40°F) or below for storage. Monitoring of the product internal temperature should be conducted at least every 2 hours until it reaches 4.4°C (40°F) or below. During storage, the chiller temperature should be continuously monitored with a daily visual check of the recorded data.
3. 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, in your HACCP plan for cooked surimi based products, titled “LINE 3 PRODUCTS – FROZEN BULK PACK”, your corrective action plan at the “Cooling” critical control point to control pathogen growth and toxin formation is not appropriate. Your corrective actions do not ensure that potentially adulterated product will not be distributed and that the cause of the deviation is corrected. FDA recommends in addition to moving product to another chiller and notifying maintenance, that firms conduct a food safety evaluation on the affected product based on the total time and temperature exposures along with making appropriate adjustments or repairs to the equipment.
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 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:
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 regulation (21 CFR Part 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 the Food and Drug Administration, Attention: Aleta Flores, 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 Aleta Flores via email at aleta.flores@fda.hhs.gov. Please reference # 515032 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition