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U.S. Department of Health and Human Services

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Enforcement Actions

Blue Star Shrimp Company (dba Blue Star Seafood Inc.) 07-May-08

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

Public Health Service
Food and Drug Administration

 

555 Winderley Place, Ste. 200
Maitland, Florida 32751

Telephone: (407) 475-4700
FAX: (407) 475-4769


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-08-15

May 7, 2008

Brian Schwemmer, President
Blue Star Shrimp Company
dba Blue Star Seafood Inc.
6341 Metro Plantation Rd.
Fort Myers, FL 33912-1289

Dear Mr. Schwemmer:

We inspected your seafood processing facility, located at 6341 Metro Plantation Rd. Fort Myers, FL 33912-1289 on January 15-16, 2008. 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 Pasteurized Crab Meat, Scombroid-Toxin Forming Species, Tuna, Mahi Mahi, and Cooked Crab Products, 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 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 "Pasteurized Crab Meat" (Canned) lists a critical limit, "Randomly check temp using an inferred thermometer" at "Receiving" and, "Randomly check daily" at the "Storage" critical control points that are not adequate to control the food safety hazard of Clostridium botulinum toxin formation. Your critical limits at the "Receiving" and "Storage" critical control points must ensure that the products are received and stored at an appropriate temperature. FDA recommends that these types of products be transported, received, and held continuously at or below 40 degrees F.

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 "Cooked Crab Products" (Ready-to-eat Stone Crabs) lists a monitoring procedure at the "Receiving" critical control point that is not adequate to control pathogen growth. FDA recommends either: 1) requiring transporters to provide records showing that products have been held at safe temperatures throughout transport, e.g. temperature recorder or data logger, or 2) for crabs that are received on ice, ensuring the safe conditions were maintained throughout shipping, such as monitoring the adequacy of ice at receipt.

• However, your firm's HACCP plan for "Cooked Crab Products" (Ready-to-eat Stone Crabs) lists a monitoring procedure at the "Storage" critical control point that is not adequate to control pathogen growth. Your firm's HACCP plan includes an established monitoring procedure of "[redacted]" Although your critical limit states that the cooked crab product must be iced, your monitoring procedure does not incorporate checking the adequacy of ice. Whereas the daily visual check of ice is adequate to control the food safety hazard, your practice of relying on daily checks of your cooler temperatures is not sufficient. In the absence of checking the adequacy of ice, for refrigerated products, FDA suggests the use of a method of continuous temperature monitoring such as a high temperature alarm with 24 hour monitoring capabilities that monitors the temperature of the cooler. This monitoring frequency should be continuous by the instrument itself with a visual check of the instrument at least once a day.

• However, your firm's HACCP plan for "Pasteurized Crab Meat" (Canned) lists a monitoring procedure at the "Receiving" critical control point that is not adequate to control the hazard of Clostridium botulinum. FDA recommends either: 1) requiring transporters to provide records showing that products have been held at safe temperatures throughout transport, e.g. temperature recorder or data logs, or 2) some other equivalent method of ensuring the safe conditions were maintained throughout shipping.

• However, your firm's HACCP plan for "Pasteurized Crab Meat" (Canned) lists a monitoring procedure at the "Storage" critical control point that is not adequate to control the hazard of Clostridium botulinum. Your firm's HACCP plan includes an established monitoring procedure of [redacted]. For refrigerated, ready to eat products, FDA recommends the use of a continuous temperature monitoring device that is capable of generating a record of the monitoring activity, to monitor the temperature of the cooler. The continuous monitoring device should be checked visually, at least once a day.

3. You must implement the record keeping systems that you listed in your HACCP plans, to comply with 21 CFR 123.6(b).

• However, your firm did not record monitoring observations at the "Receiving" and "Storage" critical control points to control the hazard of C. botulinum toxin formation listed in your HACCP plan for "Pasteurized Crab Meat" Canned (specifically, a temperature check, for products deliveries on 01/04/2008 and 01/08/2008).

• However, your firm did not record monitoring observations at the "Receiving" and "Storage" critical control points to control the hazard of scrombotoxin listed in your HACCP plan for "Scombroid-Toxin. Forming Species, Tuna, Mahi Mahi SPP" (specifically, a temperature check and a check for the presence of ice, respectively, for products delivered on 01/04/08; 01/07/08, 01/08/08, and 01/12/08).

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 CFR 123.7(b).

• However, your corrective action plan for "Cooked Crab Products". (Ready to eat Stone Crabs), at the critical control point of storage is inadequate in that it does not include appropriate actions such as "add ice to reduce temperature and holding the product for evaluation based on time/temperature exposure."

• However, your corrective action plan for "Scombroid-Toxin Forming Species, Tuna, Mahi Mahi SPP", at the critical control point-of storage does not include appropriate actions for temperature deviations such as, investigating the cause of the critical limit deviation, and measures taken to prevent the recurrence of the deviation.

• However, corrective action plan for "Pasteurized Crab Meat" (Canned) at the critical control point of storage does not include appropriate actions for temperature deviations such as holding the product for evaluation.

5. You must 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, your firm failed to maintain any sanitation monitoring records since October 31, 2007. Your firm has not maintained any records of the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion 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. 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: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District