Inspections, Compliance, Enforcement, and Criminal Investigations

PT. GALAXY NUSA DUA 12/29/17

 

  

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5001 Campus Drive
College Park, MD 20740 

 

WARNING LETTER
 DEC 29, 2017
 
VIA EXPRESS DELIVERY
 
Mr. Abdul Rahman
Director                                                                                                                                                                                                                          
PT. Galaxy Nusa Dua
JL Jati waringin Raya No. 260.D
Bekasi, Jawa Barat,17530
Indonesia
 
Reference # 541832
 
Dear Mr. Abdul Rahman:
 
On October 12 - 25, 2017, a representative of the United States Food and Drug Administration (FDA) inspected an importer of seafood products, located in the United States, Gourmet Fusion Foods Inc., located in Culver City, CA. That importer was found to be importing fish and fishery products from your processing facility. During the inspection of the importer, we collected a copy of your HACCP plan entitled “Frozen Tuna”, dated February 27, 2016.
 
Review of your HACCP plan (copy attached), revealed that this plan demonstrates serious deviations from the requirements of the seafood HACCP regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). 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 frozen vacuum packaged 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.
 
We found 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 Frozen Tuna does not list the critical control point or multiple critical control points for unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation. FDA recommends that your firm include a critical control point or individual critical control points to monitor the cumulative time and temperature of exposure from when the first fish in the lot is received until the last finished fish from the lot is placed in the freezer. Because your frozen tuna product is consumed as sushi and is considered a raw Ready to Eat (RTE) product, you should also identify the food safety hazard of pathogen growth as a reasonably likely hazard. 

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, your HACCP plan entitled “Frozen Tuna” lists critical limits at the following critical control points which are not adequate to control the food safety hazards of Clostridium botulinum toxin formation and scombrotoxin (histamine) formation. Specifically,
 
a.  At the “ (b)(4)” critical control point, your critical limits are not adequate to control Clostridium botulinum toxin formation. FDA recommends:
  • For refrigerated (not frozen) storage or processing of raw material, in-process product, or finished product held under reduced oxygen conditions:
o   The product is held at a cooler temperature of 38°F (3.3°C) or below with continuous monitoring;
OR
  • For raw material, in-process product, or finished product stored under ice:
o   The product is completely and continuously surrounded by ice throughout the processing/storage time.
 
b.  At the “(b)(4)” critical control point, your critical limits are not adequate to control scombrotoxin (histamine) formation that is reasonably likely to occur during transit from the supplier to the processing plant. (b)(4). Internal temperature measurements at the time of delivery by themselves are not adequate to control scombrotoxin (histamine) formation that is reasonably likely to occur during transit from the supplier to the processing plant. To control scombrotoxin (histamine) formation that is reasonably likely to occur during transit from the supplier to the processing plant, FDA recommends that:
  • For fish delivered refrigerated (not frozen):
o   All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit;
OR
  • For fish delivered under ice:
o   Fish are completely surrounded by ice at the time of delivery.
  
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 for your tuna at the “(b)(4)” critical control point to control Clostridium botulinum toxin formation does not ensure that the cause of the deviation is corrected and that no adulterated product enters commerce. FDA recommends that, in addition to segregating and destroying any label stock that does not contain the proper statement and determining and correcting the cause of improper labels, firms also segregate and relabel any improperly labeled product.
 
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., records for the production of 5 production date codes of the 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 applicable laws and regulations. In addition, we request that your response provide a description of the types of suppliers which provide tuna to your facility, i.e. primary processors and/or harvest vessels. Submission of the information in English will assist in our review. 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. You may view this alert at http://www.accessdata.fda.gov/cms_ia/ialist.html.
 
Please send your reply to Food and Drug Administration, Attention: Aleta Flores, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Flores via email at aleta.flores@fda.hhs.gov. Please reference CMS# 541832 on any submissions and within the subject line of any emails to us. 
 
 
Sincerely,
/S/ 
William A. Correll
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition
 

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