- Delivery Method:
- Via Express Delivery
- Reference #:
- Food & Beverages
Recipient NameMr. Albert Winson
- PT. Winson Prima Sejahtera
Jl. Pulau Solor No. 11 KIM-11
Saentis, Percut Sei Tuan
North Sumatra 20371
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
Reference # 660935
Dear Mr. Albert Winson:
The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, located at Jl. Pulau Solor No. 11 KIM-11 Saentis, Percut Sei Tuan, North Sumatra, Sumatera Utara, Indonesia 20371, on April 02 - 09, 2023. During the remote assessment, we found that you had serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the assessment, the FDA investigator discussed items of concern. To date, your firm has not responded to the discussion items identified during the FFRA.
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 wild, frozen, vacuum packaged, ready-to-eat yellowfin tuna is adulterated, in that it has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Your significant deviations are as follows:
1. You must conduct or have conducted a hazard analysis for your wild, frozen, vacuum packaged, ready-to-eat yellowfin tuna 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." However, your firm’s HACCP plan does not list the food safety hazard of pathogen growth, including Salmonella, which can be introduced during (b)(4) processing steps for your ready-to-eat raw tuna products (e.g., ground tuna, saku, tuna chunks). Cumulative time exposures should be limited to 2 hours when ambient temperatures (e.g., water, air) are not controlled and/or exceed 21.1°C (70°F) to prevent pathogen growth.
2. You must have a HACCP plan that at 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 “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 HACCP plan lists a critical limit “(b)(4)” at the (b)(4) critical control point that does not provide the necessary safety assurance needed to prevent histamine formation as required by 21 CFR 123.6(c)(3). FDA recommends listing critical limits that address the ambient temperature (e.g. air, water) in the storage area to assure the safety of all fish units.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). Your firm’s HACCP plan lists a monitoring procedure “(b)(4)” at the receiving critical control point (CCP) to control scombrotoxin (histamine) formation. However, you are not implementing the recordkeeping system, monitoring procedures, or maintaining the necessary monitoring records as required by 21 CFR 123.6(b). Specifically,
a. Your records show that internal temperatures were not consistently monitored at receiving CCP. For example, your “(b)(4)” from Supplier (b)(4) showed the internal temperatures were missing for No. 4, 5, 6 and for supplier (b)(4) No. 3. Also, the Receiving Raw Material record dated 31/7/22 No. 74 – 108 was missing internal temperatures.
4. Since you chose to include corrective actions in your HACCP plan, your corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective actions at the (b)(4) critical control point for histamine testing, decomposition, and internal temperatures, are not adequate to ensure that affected product is not entered into commerce and that the cause of the deviation was corrected as required by 21 CFR 123.7(b). Specifically,
a. Your corrective action listed “(b)(4)”, does not list controls that address correcting the cause of the critical limit deviations.
b. Your corrective action lists “(b)(4)” for (b)(4) fish that will be tested for histamine does not include a statement that none of the fish tested should have histamine levels at or above (b)(4) ppm.
c. Your monitoring records dated from August 01 – 20, 2022 corresponding to your corrective action “(b)(4)” do not show when you implemented the corrective action, in response to your critical limits of “(b)(4)” being exceeded. For example, the Histamine Test Result records showed your critical limits were exceeded, specifically:
i. August 06, 2022 for Group (b)(4) shows (b)(4) ppm histamine
ii. August 04, 2022 for Group (b)(4) shows (b)(4) ppm histamine and Group (b)(4) shows (b)(4) ppm histamine
iii. August 03, 2022 for Group (b)(4) shows (b)(4) ppm histamine and Group (b)(4) shows (b)(4) ppm histamine. No records were provided to the investigator showing the retest results and whether the affected fish were effectively rejected.
Your firm should consistently follow the monitoring procedures and corrective actions to ensure that the seafood products you prepare, pack or hold do not deviate from the indicated control measures established in your HACCP plan.
For additional guidance you may reference the Fish and Fishery Products Hazards & Controls Guidance - June 2022 Edition at https://www.fda.gov/media/80637/download, Chapter 12 Pathogenic Bacterial Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse.
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 believe that your product is not in violation of the Act, 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. 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 Current Good Manufacturing Practice regulation (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.
You should direct your written reply to Giselle Jordan, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Giselle Jordan via email at Giselle.email@example.com. Pease reference CMS #660935 on any submissions and on the subject line of any emails to us.
Ann M. Oxenham, J.D.
Office of Compliance
Center for Food Safety and Applied Nutrition