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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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JC's Fish & BBQ Inc. 5/1/12

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

May 1, 2012
 
2012-DAL-WL-017
 
 
WARNING LETTER
 
                                                                                                           
UPS OVERNIGHT
 
 
Cynthia L. Hudson, President
JC’s Fish and BBQ, Inc.
302 Highway 315, Suite A
Knoxville, Arkansas 72845-9007
 
Dear Ms. Hudson:
 
We inspected your seafood processing facility, located at 302 Highway 315, Suite A, Knoxville, Arkansas, on February 6th through 8th, 2012. 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 spoonbill 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 and labeling regulations, 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 spoonbill (paddlefish) roe does not list the critical control point (CCP) of finished product refrigerated storage for controlling the food safety hazard of pathogens including Clostridium botulinum.
 
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for spoonbill roe lists monitoring procedures and/or frequencies at the (b)(4) critical control point that are not adequate to control pathogens, including C. botulinum.
 
Specifically, your HACCP plan lists a critical limit at the (b)(4) CCP of (b)(4) to control pathogens, including C. botulinum, in the finished product, with a monitoring frequency of “Send sample in for test (b)(4)”. However, FDA recommends that (b)(4) analysis is performed on (b)(4) of finished product.
 
3. 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 plan for spoonbill roe at the (b)(4) critical control point to control C. botulinum is not appropriate.
 
Specifically, your HACCP plan at the (b)(4) CCP lists a corrective action of “If not right (b)(4) Test (b)(4)”. This corrective action does not address ensuring that adulterated product does not enter commerce, and it also does not address finding and correcting the cause of the deviation.
 
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). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
 
For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
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: Seri L. Essary, Compliance Officer, at the above letterhead address. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214) 253-5335.
 
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director