|Company:||Capitan's Select Seafood, Inc.|
|Subject:||CGMP for Foods/Seafood HACCP/Adulterated|
|Issuer:||Minneapolis District Office|
|Issued:||Feb. 17, 2006||Closed:||
Department of Health and Human Services
Public Health Service
Minneapolis District Office
February 17, 2006
RETURN RECEIPT REQUESTED
Refer to MIN 06- 20
Carolyn M. Young
Captain's Select Seafood, Inc.
214 22nd Avenue North
Minneapolis, MN 55411-2214
Dear Ms. Young:
S We inspected your seafood processing facility, located at 214 22nd Avenue North, Minneapolis, Minnesota, on January 11-13 and 18, 2006. 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 and 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 Finfish including histamine producing fish, Molluscan, Shellfish, Oysters and refrigerated canned pasteurized crab meat and smoked fish 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 conduct or have conducted for you 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 you 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 canned pasteurized crab meat or smoked fish to control the food safety hazard of pathogen growth.
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:
a. Finfish including Histamine Fish lists a monitoring procedure(s) / frequency at the Receiving and Storage critical control points that are not adequate to control pathogen growth and scrombotoxin formation.
Specifically, your HACCP plan requires you to check the temperature of your product upon receipt: However, checking the temperature only at receipt leaves a gap of unknown quantity of hours during transport of these products. As many of these products are received from locations well outside the boundaries of the state, this is sufficient time for temperatures to fluctuate, rising sufficiently over an unmonitored and extended time period to allow for pathogen growth and toxin formation and also for dropping back down to a safe temperature before the receiving CCP check of the temperature. As such, the monitoring frequency currently employed by your firm is inadequate to control pathogen growth and toxin formation.
b. Molluscan Shellfish, Crustaceans, and Oysters list a monitoring procedure/ frequency at the Receiving and Storage critical control points that are not adequate to control pathogen growth.
Specifically, your HACCP plan requires you to check the temperature of your coolers twice daily. In practice, you additionally use continuous temperature recording in your coolers. However, the recording charts are not calibrated and do not achieve agreement with the handheld thermometers which are calibrated. Indeed, the temperature recordings for your "shellfish" cooler are repeatedly well above the thermometer readings. No corrective actions have been documented on these findings and there is no documentation that these charts are reviewed. Therefore, manually checking the temperature twice daily leaves a gap of several hours between temperature checks and no monitoring of the overnight storage of these products. This is sufficient time for temperatures to fluctuate, rising sufficiently over an unmonitored and extended time period to allow for pathogen growth and toxin formation and also for dropping back down to a safe temperature before the next production check of the temperature. As such, the monitoring frequency currently employed by your firm is inadequate to control pathogen growth and toxin formation.
3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the Receiving critical control point to control pathogen growth listed in your HACCP plan for Molluscan Shellfish, Crustaceans, and Oysters.
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 123) and the Current Good Manufacturing Practice regulation (21 CFR 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 Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612)758-7114.
W. Charles Becoat