Inspections, Compliance, Enforcement, and Criminal Investigations
Philippine Cinmic Industrial Corp 7/26/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|College Park, MD 20740|
JUL 26, 2012
VIA EXPRESS DELIVERY
Ms. Lea Cuizon-Cabaluna
Quality Assurance Manager
Philippine Cinmic Industrial Corp.
General Santos City
Reference No. 320178
Dear Ms. Cuizon-Cabaluna:
On April 16, 2012, the U.S. Food and Drug Administration (FDA) requested your seafood manufacturing facility, Philippine Cinmic Industrial Corp., located at Cabu Tambler, General Santos City, Philippines, send us a copy of the HACCP plan, hazard analysis, product flow diagrams and five days worth of monitoring records for your fresh frozen tuna treated with carbon monoxide (CO) destined for the U.S. market. You sent us the materials via email on April 21, 2012. After a review of the documentation, we find that you have serious deviations from the Seafood Hazard Analysis and Critical Control Point (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 to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the fishery products adulterated within the meaning of section 402(a)(4) of the U.S. Federal Food, Drug and Cosmetic Act (the Act), [21 USC 342(a)(4)]. Your firm's fresh frozen tuna treated with carbon monoxide is adulterated, in that the product has been prepared, packed, or held under conditions whereby it 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 Hazards Guide can be found on our web site at:
Your significant violations are as follows:
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 fresh frozen tuna treated with CO does not list the appropriate critical control points (CCPs) to control the food safety hazards of scombrotoxin formation and undeclared allergens. Specifically, the plan fails to have the following critical control points:
a. Receiving critical control point for fish received at the dock to control scombrotoxin formation. Your firm is a primary processor of the fish and, as a primary processor, FDA recommends that you include a critical control point for receipt of the fish at the wharf at the time they are off-loaded from the boats (i.e., prior to being transported to your facility), in addition to the "Plant Receiving" critical control point listed in your plan. FDA also recommends that you monitor temperatures of the fish at off-loading to ensure that the fish were held at proper temperatures during storage onboard the boats.
b. Labeling critical control point to control the hazard of undeclared allergens (i.e., fish protein). Your HACCP plan should include a CCP to ensure that all labels of your fish declare the correct species of fish.
2. 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 fresh frozen tuna treated with CO lists inadequate monitoring procedures at the following critical control points:
a. (b)(4) critical control point: Although you as a CCP, your monitoring procedure references start and end of processing during the production day, not overnight. Consequently, you have no monitoring procedures or frequency for this critical control point associated with overnight storage in the truck. Your firm should implement monitoring procedures to ensure that proper temperatures are maintained during the overnight storage in the trucks.
b. "Chilling" critical control lists that you will monitor temperatures of the chiller (b)(4) during working hours. However, intermittent temperature checks provide information about temperatures between the checks. Moreover, checking (b)(4) during working hours will provide no information about the temperatures during those periods when your employees are not working, such as overnight and during weekends. FDA recommends continuous monitoring and recording of the temperatures, with daily checks of your chiller to ensure that proper temperatures are consistently maintained during all storage times.
3. Predetermined corrective action plans included in the firm's HACCP plan, 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 plan is not appropriate for fresh frozen tuna treated with CO at the storage and chilling critical control points to control histamine formation and Clostridium botulinum, as follows:
a. (b)(4) CCP: You have not listed how your firm will correct cause of the deviation. Additionally, your action of adding ice when ice is found insufficient at the time of monitoring is not adequate because re-icing temperature abused fish will not prevent the distribution of potentially adulterated products.
b. "Chilling" CCP:
ii. Your plan lists testing for Clostridium botulinum as a corrective action, which is not adequate because all product would need to be tested for the presence of toxin to provide assurance that no adulterated product enters into commerce. FDA does not recommend product testing as a corrective action associated with pathogen growth and potential toxin formation.
ii. You have listed testing for histamine; however, you have not listed the testing parameters such as number of samples and histamine levels.
iii. You have not identified final disposition of product that did not meet your critical limits or corrective action plans.
iv. You have not listed measures to regain control of the operation, such as repairing or making adjustments to the cooler.
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; 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 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
Please send your reply to the Food and Drug Administration, Attention: Carol D'lima, CFSAN Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: Carol.Dlima@fda.hhs.gov. Please reference FEI #3006495651 on any submissions and within the subject line of any emails to us. You may also contact Carol D'lima at (240) 402-2033 or by email if you have any questions about this letter.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition