DEPARTMENT OF HEALTH & HUMAN SERVICES
March 22, 2012
VIA OVERNIGHT DELIVERY
Mr. Nontapong Singhalachat,
MMP International Co. Ltd,
Reference No.: 276357
Dear Mr. Singhalachat:
We inspected your seafood manufacturing facility, MMP International Co. Ltd. located at 19/8 MOO6, Tambol Nadee, Muang District, Thailand, on September 8 and 9, 2011. 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.
Accordingly, your tuna and crabmeat products are adulterated, in that they have been prepared packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
We acknowledge receipt of your responses provided on September 17, 2011 and February 7, 2012. These responses included a revised HACCP plan for your crabmeat and pictures of changes made to address observations of concern noted on the FDA-483 issued at the conclusion of the inspection. Our review revealed that the response was not adequate, as described below.
We note the following serious deviations from the requirements of the Seafood HACCP regulation:
You must conduct 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(c)(1). A food hazard is defined in 21 CFR 123.3(b) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for tuna (collected during the inspection) and your revised plan for crabmeat submitted with your response do not list the food safety hazard of Staphylococcus aureus toxin formation. Because these products undergo significant handling at ambient temperatures for extended time periods prior to the canning process, there is a potential for Staphylococcus aureus toxin formation.
For additional information related to pathogenic bacterial growth and toxin formation (other than Clostridium botulinum), please see Chapter 12 of FDA’s 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide). For additional information specifically related to Staphylococcus aureus please see Chapter 15. You can access the Hazards Guide from our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
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 (CCP) 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 tuna, collected during the inspection, does not list several necessary critical control points to control scombrotoxin (histamine) formation.
For example, our inspection revealed several steps that likely pose a potential for excessive scombrotoxin (histamine) formation due to time and temperature abuse. Specifically, our investigator noted that your firm conducts steps(b)(4). All of these steps are conducted prior to the start of the retort operation, and can lead to excessive histamine development. For additional information related to scombrotoxin (histamine) formation controls as a primary processor, please see Chapter 7 of FDA’s 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance
- You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for your tuna, collected during the inspection, does not list adequate monitoring procedures at the receiving critical control point, as follows:
Your plan does not include the date and time of the offload of the fish as a monitoring procedure.
You also list monitoring each lot for decomposition and each truck for histamine testing; however, FDA recommends monitoring per lot instead of truck loads since there may be more than one lot per truck.
For both your tuna and crabmeat, at your labeling critical control point, you list that that your firm will review the label on the pallets; however, this type of monitoring does not ensure that the correct product is placed in the appropriately labeled container. FDA recommends controls to ensure the product is appropriately labeled with the specific fish type. In addition we recommend that you review the filling liquid for allergenic substances to ensure that they are appropriately labeled.
- 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 Receiving critical control point is not adequate. It does not list the specific corrective actions that will be taken when you exceed the histamine level to prevent distribution of potentially adulterated products and to correct the cause of the deviation.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act and the fish and fishery products regulations (21 CFR Parts 123). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Carol D’lima, Office of Compliance, Division of Enforcement, Food Assessment Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. D’lima at (240) 402-2033 or via email at Carol.Dlima@fda.hhs.gov.
Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition