| Public Health Service Food and Drug Administration |
Seattle District |
Department of Health and Human ServicesApril 13, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-12
Ms. Sandra E. Haber, President
Happy Crab Seafood, Inc.
2601 N. Newark Street
Portland, Oregon 97217-6927
WARNING LETTER
Dear Ms. Haber:
We inspected your seafood processing facility, located at 2601 N. Newark Street, Portland, Oregon, on January 12, 19, and 21, 2011. 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 crab meat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may 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:
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 “Cooked crabmeat from live crab processed at our plant” does not list the critical control points of cooking for controlling the food safety hazard of pathogen survival and cooling of the cooked crabs to control pathogen growth and toxin formation. The critical control point should include the minimum or maximum values for the critical factors established by a scientific study. Your firm currently monitors the rolling boil of the cook water. This should be listed as a critical limit. Additional critical limits may include, but are not limited to, the length of the cook cycle, a visual confirmation of a rolling boil for water used for cooking, initial temperature of the crabs, and the size of each batch. In addition, in order to reduce the likelihood for post-cook contamination, FDA recommends that cooked seafood be cooled to below 70 F within two hours.
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).
a. However, your firm’s HACCP plans for both “Crabmeat processed from cooked, frozen crab sections shipped to us from cannery” and “Cooked crabmeat from live crab processed at our plant” both list a monitoring frequency at the “Meat Processing” critical control point that is not adequate to control “Pathogen Growth due to Temperature Abuse.” Your plans list a frequency of “At the end of meat processing and whenever deemed necessary by supervisor.” FDA recommends monitoring internal temperatures every two hours.
b. However, your firm’s HACCP plans for “Crabmeat processed from cooked, frozen crab sections shipped to us from cannery” and “Cooked crabmeat from live crab processed at our plant” do not list adequate monitoring frequency at the “Icing/Master-casing/Cooling (post-packing)” critical control point to control Pathogen Growth due to Temperature Abuse.” FDA recommends the adequacy of ice during storage be monitored at least twice daily.
3. 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."
a. However your firm’s HACCP plan for both “Crabmeat processed from cooked, frozen crab sections shipped to us from cannery” and “Cooked crabmeat from live crab processed at our plant” lists a critical limit “Harvester the company buys the product from must be licensed; harvester must follow the National Shellfish Sanitation Program regulations” at the “Receiving” critical control points that are not adequate to control environmental chemical contaminants and pesticides.
These critical limits do not identify a value to which a feature of the process must be controlled in order to control the hazard. Our inspection revealed that in practice you are obtaining a certificate accompanying the live crab that indicates the area the crab was obtained from, but you are not correlating the area information to information that identifies areas closed to harvesting or under consumption advisories. You should identify harvest areas for receiving of crab to ensure the animals were not harvested from areas that have been closed. The areas should be monitored that are closed to commercial fishing or under a consumption advisory by federal, state or local authorities.
a. However, your firm’s HACCP plan for “Crabmeat processed from cooked, frozen crab sections shipped to us from cannery” lists a critical limit “Temperature must not exceed (b)(4) F; product must return (b)(4)F within (b)(4) hours” at “Meat Processing” critical control point that is not adequate to control “Pathogen Growth due to Temperature Abuse.”
b. However, your firm’s HACCP plan for “Cooked crabmeat from live crab processed at our plant” lists a critical limit “Temperature must not exceed (b)(4)F; product must return to cooler within (b)(4) hours” at “Meat Processing” critical control point that is not adequate to control “Pathogen Growth due to Temperature Abuse.”
Your critical limits listed as “Temperature must not exceed (b)(4)F; product must return to cooler within (b)(4) hours” and “Temperature must not exceed (b)(4)F; product must return (b)(4) F within (b)(4) hours” are inappropriate because our investigator observed that the step occurring before this process is a cooking step. Consequently, it is expected that the temperature of the product is expected to be above (b)(4)F at the start of this “meat processing” critical control point. The product would have already exceeded the (b)(4)F limit at the start of the “meat processing” critical control point. Chapter 12 of the Fish and Fisheries Products Hazards & Controls Guidance: Third Edition can provide guidance in determining the appropriate controls for your process.
4. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7).
a. No records are maintained for monitoring the amount of ice surrounding the product at the “Icing/Master-casing/Cooling (post-packing)” critical control point.
b. In addition, your firm did not record actual values and monitoring observations on the “Time/Temperature Log” for monitoring at the “Meat Processing” critical control point to control “Pathogen Growth due to Temperature Abuse” listed in the HACCP plan “Crabmeat processed from cooked, frozen crab sections shipped to us from cannery.” Specifically, monitoring records reviewed between the dates January 5, 2011, and February 16, 2011, include recordings such as <(b)(4),< (b)(4), and <(b)(4) rather than actual values and observations obtained during monitoring.
5. 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 plans for “Crabmeat processed from cooked, frozen crab sections shipped to us from cannery” at the “Meat Processing” and the “Icing/Master-casing/Cooling (post-packing)” critical control points; and the “Cooked crabmeat from live crab processed at our plant” at the “Receiving,” “Meat Processing” and the “Icing/Master-casing/Cooling (post-packing)” critical control points are not adequate. The corrective actions for these critical control points do not list how you intend to correct the cause of the deviation.
For your information it was noted during the inspection that your firm utilizes ice to control the temperature of the product at various production steps. If you are using ice to maintain critical limits, it should be listed in your HACCP plan.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (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: Patricia A. Pinkerton, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have questions regarding any issues in this letter, please contact Patricia Pinkerton at 425-483-4926.
Sincerely,
/s/
Charles M. Breen
District Director
No comments:
Post a Comment