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U.S. Department of Health and Human Services

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Enforcement Actions

American Seaway Foods 5/22/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
6751 Steger Dr.
Cincinnati, OH 45237 

 

VIA United Parcel Service
 
May 22, 2013
 
Laura Karet, Chief Executive Officer
Giant Eagle, Inc.
101 Kappa Drive
RIDC Park
Pittsburgh, PA 15238
 
WARNING LETTER CIN-DO 13-397275-25
           
Dear Ms. Karet:
 
We inspected your seafood warehouse, American Seaway Foods, 5300 Richmond Rd., Bedford Heights, OH, on April 3 – 17, 2013. 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 (21 CFR 123). 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 refrigerated seafood 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, the seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
 
Your response dated May 6, 2013, has been received. However, your response is not adequate because the deviations noted during the inspection have not been corrected. Moreover, further review has identified additional deviations, which are included below. 
 
Your significant violations are as follows:
 
1)    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 your must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for refrigerated, raw canned scallops.
 
2)    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(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.”  
 
a)    Your firm’s HACCP plan for ready to eat pasteurized crabmeat does not list the food safety hazard of Clostridium botulinum (C. botulinum)toxin formation.
 
b)    Your firm’s HACCP plans for ready to eat sushi and ready to eat tuna salad do not list the food safety hazard of pathogen growth and toxin formation.
 
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)    Your firm’s HACCP plans for sushi, ready to eat tuna salad, and fresh tuna, marlin, mackerel, et al. list a critical limit at the receiving critical control point that is not adequate to control the food safety hazard of scombrotoxin (histamine) formation.
 
b)    Your firm’s HACCP plans for ready to eat pasteurized crabmeat and ready to eat seafood salads list a critical limit at the receiving critical control point that is not adequate to control the food safety hazard of pathogen growth and toxin formation.
 
4)    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)    Your firm’s HACCP plans for sushi, ready to eat tuna salad, fresh tuna, marlin, mackerel, et al. lists a monitoring frequency at the warehouse storage critical control point that is not adequate to control histamine formation.
 
b)    Your firm’s HACCP plans for ready to eat pasteurized crabmeat, and ready to eat seafood salads lists a monitoring frequency at the warehouse storage critical control point that is not adequate to control pathogen growth and toxin formation.
 
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).  
 
a)    The corrective action plan listed in your HACCP plans for sushi, ready to eat tuna salad, and fresh tuna, marlin, mackerel, et al. at the receiving critical control point to control scombrotoxin (histamine) formation is not appropriate. Specifically, the corrective actions do not ensure that the cause of the deviation has been corrected.
 
b)    The corrective action plan listed in your HACCP plans for ready to eat pasteurized crabmeat and ready to eat seafood salads at the receiving critical control point to control pathogen growth and toxin formation is not appropriate. Specifically, the corrective actions do not ensure that the cause of the deviation has been corrected. 
 
c)    The corrective action plan listed in your HACCP plans for sushi, ready to eat tuna salad, and fresh tuna, marlin, mackerel, et al. at the storage critical control point to control scombrotoxin (histamine) formation is not appropriate. Specifically, the corrective actions do not address what action to take with product involved in a critical limit deviation. 
 
d)    The corrective action plan listed in your HACCP plans for ready to eat pasteurized crabmeat and ready to eat seafood salads at the storage critical control point to control pathogen growth and toxin formation is not appropriate. Specifically, the corrective actions do not address what action to take with product involved in a critical limit deviation. 
 
We suggest that you use the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition to evaluate your firm’s operation regarding seafood products. While the guidance is not a binding set of requirements it does provide information that will most likely result in a HACCP plan that is acceptable to FDA. Firms may choose other control measures, but they are then responsible for scientifically establishing their adequacy. 
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm complies with the Act, the seafood HACCP regulations (21 CFR Part 123), the Current Good Manufacturing Practice regulations (21 CFR Part 110), and the Food Labeling regulations (21 CFR Part 101). You should take prompt action to correct these violations. Failure to correct these violations in a prompt manner may result in regulatory actions without further notice, such as seizure, injunction, and/or prosecution.
 
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act.  Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with reinspection.  A reinspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved.  Reinspection costs include all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees. FDA will assess and collect fees associated with this reinspection in accordance with Section 743 of the Act. 
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your reply should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. Your response should outline the specific steps you have taken to correct these violations. Your response should include your revised HACCP plans and any 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.
 
If you have questions regarding any issue in this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 2164 or karen.sego@fda.hhs.gov.
 
Sincerely,
/S/ 
David L. Miser
Acting District Director
Cincinnati District