Inspections, Compliance, Enforcement, and Criminal Investigations
JC's Fish and BBQ, Inc. 19-Jun-07
Department of Health and Human Services
Public Health Service
June 19, 2007
RETURN RECEIPT REQUESTED
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 March 19-20, 2007. 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 Part 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 Paddlefish (Spoonbill) Roe 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:
1. 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 Spoonbill Roe does not list adequate monitoring procedures and frequency at the "Salting" critical control point to control Clostridium botulinum growth and toxin formation. Specifically, your HACCP Plan lists that you will monitor "salt" and "chart weights." For your listed critical limit ([redacted]% water phase salt), FDA recommends a monitoring procedure consisting" of lot-by-lot laboratory analysis (i.e., for each batch). As an alternative, you could consider establishing and monitoring critical limits for your process, such as salt/roe ratio and holding or draining time for salted roe, that consistently result in a [redacted]% water phase salt level and using analytical testing only as a verification procedure.
2. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogen growth and toxin formation when your process for Spoonbill Roe deviated from your critical limit at the "salting" critical control point. Specifically, the testing that was performed in December 2006 revealed that you exceeded your critical limit of [redacted]% water phase salt. You did not perform any corrective actions to identify an correct the cause of your process exceeding your critical limit (e.g., modify formulation), to prevent future occurrences, and to prevent potentially unsafe product from entering commerce (e.g., reprocess, destroy the product). We note that "Freezing" inadequately processed product that is intended to be sold refrigerated in reduced oxygen packaging at temperatures is not an adequate control.
3. You must fully document in your records all corrective actions taken, to comply with 21 CFR 123.7(d). Your continuous monitoring records for the time period of 11/15/06 through 2/5/07 indicate seven occasions during the roe processing season when your refrigerated storage temperature for Spoonbill Roe exceeded your critical limit of [redacted]F. However, you did not document that a corrective action was taken when you deviated from your critical limit.
4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR123.7(b). However, your corrective action plan for Spoonbill Roe at the "Receiving," "Salt," and "Storage" critical control points to control pathogens, including Clostridium botulinum growth and toxin formation, is inadequate because it does not adequately describe the procedures you will use if your critical limits have not been met. Specifically, your corrective actions do not list procedures that will address the cause of the deviation so that future deviations will not occur and procedures to prevent potentially unsafe product from entering commerce.
In addition to the deviations described above, we note that your 1/2 lb, 1 lb, and 3 lb containers of paddlefish roe are misbranded within the meaning of sections 403(e)(1) and (2) [21 U .S.C. §343(e)(1) and (2)] and 403(i)(1) and (2) [21 U.S.C. §343(i)(1) and(2)] of the Act for failing to bear required labeling statements. Specifically, your finished products of roe fail to bear the name and place of business of the manufacturer, packer, or distributor [21 CFR 101.5(a)] as well as a net quantity of contents statement [21 CFR 101.105(a)]. Furthermore, your product labels fail to bear the common or usual name of the food [21 CFR 101.3(a)] as well as the common or usual name of each ingredient in the ingredient list [21 CFR 101.4(a)(1)].
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 U.S. Food and Drug Administration, Attention: Sherrie L. Krolczyk, Compliance Officer, 4040 N Central, Dallas, Texas 75204. If you have questions regarding any issues in this letter, please contact Ms. Krolczky at 214-253-5312.
A. Blake Bevill
Acting Dallas District Director