| Public Health Service Food and Drug Administration |
| College Park, MD |
Department of Health and Human Services
Warning Letter
I.D. # 124469
August 11, 2010
VIA OVERNIGHT MAIL
Anita Gallardo Ossandon, CEO
Emprede SA
1212 Guillermo Cubillo St.
Tanca Marengo Km 4.5
Guyaquil, Ecuador
Dear Mrs. Ossandon:
We inspected your seafood processing facility, located at 1212 Guillermo Cubillo St., Tanca Marengo Km 4.5, Guyaquil, Ecuador on May 5 through 7, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 escolar, dorado and histamine species fish are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
- 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 Part 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 plans for Escolar and Dorado do not list the critical control point of refrigerated storage for controlling the food safety hazard of histamine formation. Your firm stores histamine species fish in a refrigerated cooler prior to cutting fillets and freezing. For refrigerated storage of histamine species fish, FDA recommends either (1) temperatures of 4.4ºC (40 ºF) or below with continuous monitoring of cooler temperatures by a digital time/temperature data logger or recorder thermometer with visual check of the instrument at least once per day; or (2) visually monitoring the adequacy of ice or chemical cooling media in a sufficient number of containers (e.g. cartons, totes, etc.) to represent all of the product at least twice per day.
- 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 firm’s HACCP plans for Escolar and Dorado list a critical limit “No mas de 5 mg de histamine por cada 100g o 50 ppm del lots que se recibe” at the Recepcion critical control point that is not adequate to control histamine formation when you composite fish for testing. Fish collected for histamine analysis may be composited; however, the critical limit must be reduced accordingly. For example, a sample of 18 fish may be composited into 6 units of 3 fish each, provided the critical limit is reduced from 50 ppm to 17 ppm for each unit. If you chose to composite the fish collected for histamine analysis, as was discussed with the FDA investigator during our inspection, your critical limit should be lowered to 17ppm.
Your raw, vacuum packaged seafood is frozen immediately after processing, and maintained frozen throughout distribution prior to export to the US. FDA recommends appropriate labeling as an added barrier for control of C. botulinum to ensure that product is maintained in a frozen condition until immediately before consumer use (e.g., "Important, Keep Frozen, Thaw Under Refrigeration Immediately Before Use").
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 send your reply to the Food and Drug Administration, Attention: Priya Rathnam, 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. Rathnam by phone at (301) 436-2078 or via email at Priya.Rathnam@fda.hhs.gov.
Sincerely,
/s/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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