Blackstar Fish Co Inc 4/18/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775
Via United Parcel Service
April 18, 2013
Donald R. Kinder, Owner
Blackstar Fish Company Inc.
700 Dover Road
Grand Rivers, Kentucky 42045
Dear Mr. Kinder:
We inspected your seafood processing facility, located at 700 Dover Road, Grand Rivers, KY on February 26 and 28, 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.
Your significant violations were 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 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.” However, your firm’s HACCP plan for paddlefish roe does not list the food safety hazard of Clostridium botulinum.
Based on our inspection, you are packing your paddlefish roe into plastic buckets with press-on lids. The food safety hazard of Clostridium botulinum growth and toxin formation is associated with large and deep packaged products which may create an anaerobic environment in which Clostridium botulinum can proliferate and produce toxins. FDA recommends that all finished product packages include the handling instructions to control Clostridium botulinum such as “Keep Frozen” or “Thaw under Refrigeration Immediately prior to Use”.
Furthermore, you have not conducted an analysis of your finished caviar to determine your product meets the water phase salt level.
Additionally, your firm’s HACCP plans for paddlefish caviar and paddlefish catfish do not list the food safety hazard of allergens.
2. 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 paddlefish roe does not list a critical limit at the receiving critical control point to control pathogen growth and toxin formation, as well as, Clostridium botulinum toxin formation. Specifically, your paddlefish transit time prior to delivery is not monitored for time and temperature abuse nor is the product monitored for adequate icing.
3. 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) and 123.6(c)(7). However, your firm’s HACCP plan for paddlefish roe lists monitoring procedures at the chilling and storage critical control points that are not adequate to control pathogen growth.
Your plan currently lists the product temperature will be monitored throughout processing; however, your processing record does not have an area to record the actual product temperature.
Your plan currently lists a visual check of the refrigeration unit daily, which is unacceptable. FDA recommends two methods to control pathogen growth, which are as follows:
A. A continuous temperature recording device that monitors and records the times and temperatures during refrigerated storage and performance of a daily visual check of the generated data.
B. Store product on ice and perform visual observations of the adequacy of ice in a representative number of containers from throughout the cooler at sufficient frequency to ensure the critical limit is met.
4. You must monitor and maintain sanitation control records that at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, since February 14, 2013, your firm has not monitored and documented the eight areas of sanitation listed below:
a) Safety of water;
b) Condition of food contact surfaces;
c) Prevention of cross-contamination
d) Maintenance of hand washing, hand sanitizing, and toilet facilities;
e) Protection from adulterants;
f) Proper labeling, storage, and use of toxic compounds;
g) Control of employees with adverse health conditions; and
h) Control of pests
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 Officerat (513) 679-2700 extension 2134.
Paul J. Teitell