| Public Health Service Food and Drug Administration |
| College Park, MD 20740 |
Department of Health and Human Services
March 9, 2011
Warning Letter
Case I.D. ##167893
VIA EXPRESS MAIL
Mr. Adi Widjaja, General Manager
P.T. Tuna Permata Rezeki
JL. Muara Baru Ujung Komp Transit 020
Jakarta Utara
Indonesia
Dear Mr. Widjaja,
The U.S. Food and Drug Administration inspected your seafood processing facility, located at JL. Muara Baru Ujung Komp Transit 020, Jakarta Utara, Indonesia on October 21 and 22, 2010. During that inspection, we found that you had deviations from 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 response to that FDA-483, dated November 6, 2010 that included a revised HACCP plan and descriptions of corrections made at your facility.
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 tuna is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA’s home page at www.fda.gov.
We note the following serious deviations:
- 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." However, your firm’s revised HACCP plan for “Processing Of Frozen (b)(4) submitted with your November 6, 2010 response does not list the food safety hazard of Clostridium botulinum growth and toxin formation associated with the (b)(4) of your tuna, at the “Processing (Filleting, Skinning, Trimming, Cutting, Refrigeration and Packaging) critical control point. Because the products are held in sealed bags for up (b)(4) during this (b)(4), the products pose a hazard for Clostridium botulinum toxin formation. Thus, FDA recommends that the products not be exposed to temperatures above 3.3°C(38°F) for the duration (b)(4)
- You must have a HACCP plan that, at a minimum, lists 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 for “Processing of Frozen Tuna (b)(4) submitted with your November 6th response
- does not list a critical limit associated with “Decomposition” at the “Receiving raw material” critical control point. FDA recommends analyzing a minimum of 118 fish for decomposition or analyzing the entire lot if the lot consists of less than 118 fish.
- lists a critical limit at the “Receiving raw material” critical control point that is not adequate to control histamine. Specifically, our firm lists “Adequate refrigeration upon receipt” as a critical limit, but also referenced “amount of ice at time delivery” as the monitoring procedure. Thus the critical limit associated with ice is not insufficient regarding what is considered acceptable icing of the fish. Your plan should require that the fish be surrounded with ice.
- 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 listed at the “Receiving raw material” critical control point in your revised HACCP plan for “Processing Of Frozen Tuna (b)(4) submitted with your November 6th response not appropriate to control histamine. Specifically,
- the corrective action “reject decomposed fish” is insufficient. In addition to rejecting the individual decomposed fish, when your critical limit of (b)(4) which is listed in your plan at this same critical control point, is exceeded you should be considering the entire lot as potentially unsafe and should either consider rejecting the entire lot or conducting histamine testing.
- the action listed as “Add ice and continue monitor” is inadequate because re-icing fish that have already been exposed to time and temperature abuse will not prevent distribution of potentially unsafe product.
In addition, we note the following concerns with your revised HACCP plan submitted with your November 6th response:
1. Your revised plan does not list a critical control point for the “Chilling” step. Your hazard analysis references this step but has incorrectly identified good manufacturing practices (GMPs) and Sanitation Standard Operating Procedures (SSOPs) as adequate in lieu a critical control point. However, because the tuna is held for (b)(4) during this chilling step, there is a reasonably likely potential for time and temperature abuse of the tuna which can lead to excessive histamine development.
2. Your revised plan does not list critical control points for processing steps from washing through the (b)(4) and from Trimming through Vacuum Packaging. The tuna appears to be received fresh which limits temperature exposures to (b)(4) when temperatures exceed (b)(4) when temperatures remain between (b)(4) Consequently, because you have additional processing steps, your firm should conduct your hazard analysis and determine whether your firm needs to control exposure “temperatures”; or alternatively control exposure “times” to when the fish are not held unrefrigeration, in order to ensure that your firm limits the exposure times when the fish are unrefrigerated to (b)(4)
We also continue to have concerns with regard to the open drainage canal and debris surrounding your facility. We acknowledge your response, indicating that you will install piping and clean debris. We suggest that your firm take the permanent approach by installing above ground wastewater pipes designed to continually remove sewage and wastewater as soon as possible.
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. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen 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: http://www.fda.gov/ora/fiars/ora_import_ia16120.html.
This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please direct your response the Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration 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. Benjamin by phone at (301) 436-1424 or via email at Mildred.Benjamin@fda.hhs.gov
Sincerely,
/s/
William A. Correll
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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