Inspections, Compliance, Enforcement, and Criminal Investigations
A.P. Bell Fish Company, Inc. 04-Jun-08
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
June 4, 2008
Mr. Walter T. Bell, President
A.P. Bell Fish Company, Inc.
P.O. Box 276
Cortez, Florida 34215
Dear Mr. Bell:
We inspected your seafood processing facility located at 4600 124th Street West, Cortez, Florida 34215 on February 1 & 4, 2008. 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 scombrotoxin forming species of fish 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, 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 adequately monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of water; the condition and cleanliness of food contact surfaces; the prevention of cross-contamination from unsanitary objects; the maintenance of hand washing, hand sanitizing, and toilet facilities; the protection of food packaging material, and food contact surfaces from adulteration; the proper storage of toxic chemicals; and the exclusion of pests with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
1. 21 CFR 123.11(b) (1) - Safety of Water:
o Hoses in seafood processing areas were observed not to have back-flow prevention devices.
2. 21 CFR 123.11(b) (2) - Condition and cleanliness of food contact surfaces:
o An accumulation of filth and rust was observed on food contact surfaces of seafood unloading equipment.
o Fiberglass food contact surfaces were observed to have peeling paint, chips, pits, cracks, and an accumulation of filth.
o Wooden cutting boards were observed being used that contained an accumulation of filth.
o Plastic strips in the product cooler contained an accumulation of filth and were observed coming into contact with iced seafood products.
o An accumulation of rust was observed in the ice storage closet.
o The food contact surfaces are not constructed of impervious surfaces that can be adequately cleaned and sanitized. Specifically, the wood handled shovels, wood cutting boards, and wooden totes used by the firm are direct food contact and hand contact surfaces.
3. 21 CFR 123.11(b) (3) - Prevention of cross-contamination from insanitary objects:
o Ice shovels were observed being stored directly on the floor and were then seen coming into contact with fish.
o An employee was observed standing on a crate containing ice and seafood while unstacking other crates.
o A raw fish that had fallen onto the floor during unloading was observed being removed from the floor by an employee and was added back to a pile of fish in processing without being rinsed to remove soil or other possible contamination.
o Two containers of seafood were observed being stored directly on the cooler floor.
o Employees were observed handling seafood using permeable mesh gloves that contained an accumulation of food debris.
o Plastic strips in the product cooler were observed containing an accumulation of filth from previous operations and were noted as coming into direct contact with seafood products.
o An employee was observed standing on' a crate containing seafood and ice while un-stacking other crates.
o The doorway to the ice room is pictured as having significant damage. It cannot be cleaned and sanitized. Ice is shown in direct contact with the surface.
4. 21 CFR 123.11(b)(4) - Maintenance of hand washing facilities
o No soap or paper towels were observed in the men's restroom adjacent to the processing area.
o The hand wash sink and faucet in the men's room was observed with an accumulation of filth.
o No soap or paper towels were observed at the hand washing sink in the back restroom adjacent to the fish cutting room.
5. 21 CFR 123.11(b)(5) - Protection from adulterants
o Condensate was observed dripping from the rusted product cooler ceiling where exposed seafood products were being stored underneath.
o Crates of seafood were observed being stored directly on top of exposed seafood products in crates underneath.
6. 21 CFR 123.11(b) (6) - Storage of toxic chemicals
o Liquid chlorine bleach was observed being stored in the food processing area during processing activities.
7. 21 CFR 123.11(b) (8) - Exclusion of Pests
o Birds including herons, egrets, pelicans, and sparrows were observed in the seafood processing areas during operation.
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 plan "Finfish w/histamines)" does not list the critical control point of receiving for controlling the food safety hazard of scombrotoxin (i.e., histamines) as a secondary processor.
Specifically, you receive scombrotoxin forming species from [redacted] which demonstrates that you act as a secondary processor. A review of your HACCP plan for "Finfish (w/ histamines)" revealed that it lists a critical control point (CCP) at receiving, associated only with receiving scombrotoxin forming species directly from harvest vessels and does not list safety controls for scombrotoxin forming species received from other seafood processors. Your plan should include separate safety controls for fish received from other processors. The recommended safety controls for these two situations differ significantly. Your current listed procedures do not apply.
FDA currently recommends that secondary processors, such as you, ensure that the scombrotoxin forming species of fish have been handled in a safe manner during transport to your facility. When you purchase scombrotoxin forming species from other processors or brokers, you must ensure that the fish are consistently maintained at temperatures at or below 40°F during transport to your firm. You, should monitor transport temperatures by a means that is capable of continuously recording temperatures or if product is received on ice or cooling medium by assuring that the goods are completely surrounded in ice or cooling media at receipt. Internal temperatures of fish may be monitored when fish are transported shorter distances (less than 4 hours). We suggest you refer to Chapter 7 of the Fish and Fisheries Products Hazards and Control Guidance (Third Edition) for specific recommendations for controls, monitoring procedures, and corrective actions.
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 plan for "Finfish (w/ histamines)" does list a critical limit associated with decomposition (i.e., sensory evaluation).
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 "Finfish (w/ histamines)" lists monitoring procedures/frequencies at the receiving CCP that are not adequate to control scombrotoxin formation. Specifically, the vessel monitoring record does not include any reference to cooling of the fish onboard the vessels to ensure that proper temperatures are maintained throughout the holding period. Because the fish are held on ice for several days while onboard the vessels, adequacy of ice should be monitored daily. In addition, although your plan lists "if death occurred > 24 hours ago, an int. temp < 40°F", your plan does not include any monitoring activity or procedure associated with taking internal fish temperatures at receipt.
You must implement the monitoring procedures and frequency that you have listed in your HACCP plan to comply with 21 CFR 123.6(b) and 123.6(c)(4). However, your firm did not follow the monitoring procedure of "each lot rec'd is accompanied by a vessel monitoring record" at the receiving CCP. Specifically, your firm failed to obtain harvest vessel records on several occasions.
In addition, discussions with your firm revealed that your firm is completing the harvest vessel records by interviewing the harvest vessel personnel, in lieu of having the harvest vessel personnel maintain the records while onboard the boats. These records should be completed by the employees of the harvest vessel at the time conditions are observed, and not completed by your firm at a later date.
We acknowledge receipt of an electronic letter dated May 14, 2008 from your consultant [redacted] and Seafood Specialist, stating your intended corrections to the sanitation deficiencies listed on the FDA 483 issued to our firm on February 12, 2008. The response has been reviewed and will be made part of the official file. We consider this response inadequate because it did not include any supporting documentation. Therefore, we are unable to evaluate whether corrections have been made.
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. In addition, we may not provide certificates to your firm for export of your products to European Union (EU) countries if you do not correct these deviations.
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: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763.
Emma R. Singleton
Director, Florida District