Inspections, Compliance, Enforcement, and Criminal Investigations
P.T. Super Saku Bali 7/13/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
JULY 13, 2012
VIA EXPRESS DELIVERY
Mr. Edy Suyatno, President
P.T. Super Saku Bali
Jalan Ikan Tuna Barat No.1
Denpasar, Bali 80222
Reference No. # 321879
Dear Mr. Suyatno:
We inspected your seafood processing facility P.T. Super Saku Bali located at Jalan Ikan Tuna Barat No.1, Pelabuhan Benoa, Denpasar, Bali Indonesia on March 29 and 30, 2012. 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). 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 dated April 24, 2012, that included a corrective action report and revised HACCP plans for your various forms of tuna. We have assessed the response and have continuing concerns 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 various forms of tuna 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 Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov. The 4th Edition of the Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
Your significant deviations are as follows:
1. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plans for your various forms of tuna each dated April 21, 2012 do not list adequate monitoring procedures and frequencies at the following critical control points to control histamine formation and Clostridium botulinum growth and potential toxin formation.
a. At the (b)(4) critical control points, your firm indicates that you will monitor each case of fish immediately after receiving, and again at the time of removal for processing (b)(4) to control histamine. However, FDA recommends establishing a monitoring frequency that ensures the fish are maintained at proper temperatures throughout the entire storage period.
b. At the (b)(4) critical control points, your plans do not identify adequate monitoring controls to ensure that proper handling instructions are included on each label to alert the end user that the products must be kept frozen and thawed under refrigeration immediately before use, in order to control Clostridium botulinum growth and potential toxin formation.
2. Predetermined corrective action plans included in the firm’s HACCP plans, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plans for your various forms of tuna are not appropriate at the following critical control point to controls to control histamine.
a. At the (b)(4) critical control points, your firm’s plans do not identify how you will prevent distribution of potentially adulterated products and the disposition of potentially adulterated products. (b)(4) as listed in your plans will not prevent distribution of fish that may have been time/temperature abused during storage. Additionally, your plans do not identify how your firm will correct the cause of the critical limit deviation. Your firm will be unable to implement the listed procedures associated with holding and evaluating the products based on the total time and temperature exposures during storage because your critical limits include monitoring ice only after receiving, and again at the time of removal for processing. Consequently, your firm will not have the time or temperature parameters necessary for evaluating the total time and temperature exposures. FDA recommends histamine testing as a corrective action when products have potentially been exposed to inadequate cooling during storage.
b. At the (b)(4) critical control points, your firm’s plans do not identify the disposition of potentially adulterated products and do not identify how your firm will correct the cause of the critical limit deviation.
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 plan or plans; at least five (5) product days worth of monitoring records (i.e., complete production days) to demonstrate that you have implemented the revised plan or plans; 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. 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, the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 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. You should consider providing your US Agent with a copy of this letter.
Please send your reply to Food and Drug Administration, Attention: Mildred Benjamin, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment 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 via email at Mildred.Benjamin@fda.hhs.gov
Office of Compliance
Center for Food Safety
and Applied Nutrition