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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bubbas Fish House 4/15/13

  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

 

Via United Parcel Service
 
April 15, 2013
 
Mackie E. Walker, Owner
Bubba’s Fish House
729 Easter Day Road
Grand Rivers, Kentucky 42045
 
WARNING LETTER
CIN-13-394793-17
 
Dear Mr. Walker:
 
We inspected your seafood processing facility, located at 737 Easter Day Road, Grand Rivers, KY on February 27 and March 1, 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, 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 paddlefish roe 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.
 
We acknowledge receipt of your corrective action letter dated March 11, 2013 that we received on March 18, 2013. The majority of your inspectional observations were corrected; however, your response is still inadequate. Clostridium botulinum is not being controlled during the unrefrigerated processing and monitoring steps. For more information on hazard control of Clostridium botulinum growth and toxin formation, please refer to Chapter 13 of the 4th Edition of the Hazards Guide.   
 
Your significant violations were as follows:

1.    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 revised HACCP plan for paddlefish roe does not list a critical limit at the unrefrigerated processing critical control point to control Clostridium botulinum toxin formation. Additionally, your HACCP plan for paddlefish roe does not list a critical limit at the receiving critical control point to control pathogen growth. Specifically, your paddlefish transit time prior to delivery is not monitored for time and temperature abuse nor is the product monitored for adequate icing.

Furthermore, you have not conducted an analysis of your caviar to determine your water phase salt level. 

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 paddlefish roe lists a monitoring procedure at the processing critical control point that is not adequate to control C. botulinum toxin formation. Specifically, the monitoring procedure listed at the unrefrigerated processing critical control point does not control Clostridium botulinum. The procedure listed only controls pathogen growth and toxin formation (other than Clostridium botulinum).  

3.    You chose to include a corrective action in your HACCP plan; therefore, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, the corrective action plan listed in your HACCP plan for paddlefish roe at the storage critical control point to control Clostridium botulinum is not appropriate. Specifically, your corrective action plan does not consider the time your product was unrefrigerated for product safety.

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.
 
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.
 
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 of 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 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. 
 
Please send your reply to the Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Allison C. Hunter, Compliance Officer at (513) 679-2700 extension 2134.
 
Sincerely,
/S/ 
Paul J. Teitell
District Director
Cincinnati District