| Public Health Service Food and Drug Administration |
5100 Pain Branch Parkway |
Department of Health and Human Services
March 18, 2011
Warning Letter
Case I.D. #167873
VIA EXPRESS MAIL
Mr. Fatkurochim
P.T. Indomaguro Tunas Unggul
Jakarta Fishing Port, JL.
Muara Baru Ujung
Block C/1-2
North Jakarta
Indonesia
Phone: 62-21-661-9708
Dear Mr. Fatkurochim,
The U.S. Food and Drug Administration inspected your seafood processing facility, located at Jakarta Fishing Port, JL. Muara Baru Ujung, Block C/1-2, North Jakarta, Indonesia on October 18 and 19, 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). hat 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 5, 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:
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 your (b)(4) , provided in your November 5, 2010 response does not list the critical control point for the holding period during the (b)(4) for controlling the food safety hazards of histamine and Clostridium botulinum growth and toxin formation. Our inspection revealed that following the (b)(4), the sealed bags of fish are held for (b)(4). There is a potential for histamine development, as well as Clostridium botulinum growth and toxin formation as a result of time and temperature abuse during this extended refrigerated hold period. We recommend that the fish be held at or below 38°F to control toxin formation.
2. 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). However, your firm is not following the monitoring procedures associated with the use of a continuous method of monitoring cooler storage, listed in your HACCP plan as “Digital temperature and data logger” for monitoring cooler temperatures at the “Cooler storage” critical control point to control histamine. These monitoring procedures listed your plan indicate that your firm is using a continuous thermometer and data logger for continuously monitoring and recording cooler storage; however, our inspection revealed that your firm is visually monitoring cooler temperatures every hour. In addition, your November 5th response included cooler monitoring records showing hourly temperature checks.
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, your corrective action plan in your revised HACCP plan for your tuna at the “Receiving Raw Material” and “Cooler Storage” critical control point is not appropriate to control histamine. Specifically, the action listed as “if the temperature is high, but there is no decompose re-ice and check histamine” is not appropriate because the high temperatures are indicators of the overall condition of the lot of fish at receipt and temperatures above the critical limit indicate potential abuse of the entire lot. Thus re-icing and checking histamine of individual fish does not adequately prevent the distribution of potentially unsafe fish. There is no clear explanation for the meaning of “check histamine”; however, even when conducting further histamine testing, your firm has not provided a statistically sound strategy for sampling to ensure that the sampling of the fish is sufficiently representative to detect elevated histamine levels.
In addition, during our review of your November 5th response, we noted in your monitoring records, that the critical limit for your cooler temperature was exceeded on several occasions. Although observations of the high temperatures were initialed by a plant employee, there was no evidence that a corrective action was taken consistent with the corrective actions you have listed your plan. Please be advised that you must implement and document all corrective actions taken in response to deviations from your critical limits.
In addition, we note the following concerns with regard to the HACCP plan provided in your November 5th response:
1. Your HACCP plan fails to list a critical limit as a result of the finding of decomposition at the Receiving critical control point. Although your plan indicates that you are checking every fish for decomposition, your firm should have a threshold for rejection or further testing of the lot. FDA recommends when your firm finds more than 2.5% of the fish in the lot are decomposed, that you should consider the entire lot as potentially unsafe and should either consider rejecting the entire lot or conducting histamine testing. This is because decomposition is indicative of unsafe temperature exposures which, for scombrotoxin forming species, can create conditions that may result in unsafe products. If a processor finds a significant portion of their lot decomposed, this indicates that unsafe conditions may not have been isolated and that it is uncertain if the rest of the lot is safe.
2. Your HACCP plan does not list a critical limit associated with the number of fish that will be monitored for temperature at the Receiving critical control point. Please note that FDA recommends monitoring the temperatures of at least 12 fish.
3. Our inspection revealed that your firm temporarily places the fish in an ice slurry, following receipt, until the fish are processed. This temporary holding of the fish may be necessary as a critical control point to control time and temperature abuse, if the hold time is extensive, thus creating the potential for conditions conducive to histamine formation due to exposure to elevated temperatures over the hold time.
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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