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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Simply Fresh Inc. 09-Apr-08

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office

60 8th Street, N.E.
Atlanta, Georgia 30309


April 9, 2008


VIA FEDERAL EXPRESS

Raymond T. Bohn, President
Simply Fresh Inc.
918 B Pearl Street
Durham, NC 27701-3500

WARNING LETTER
08-ATL-06

Dear Mr. Bohn:

We inspected your seafood processing facility, located at 918 B Pearl Street, Durham, North Carolina on March 11-12, 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 fresh crabmeat, pasteurized crabmeat and vacuum-packed smoked salmon are adulterated, in that they have been prepared, packed, or held under in sanitary 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 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:

• Fresh crabmeat to control the food safety hazard of pathogen growth.

• Pasteurized crabmeat to control the food safety hazard of pathogen growth and toxin formation, specifically Clostridium botulinum.

• Vacuum-packed smoked salmon to control the food safety hazards of pathogen growth and toxin formation, specifically Clostridium botulinum.

2. You must implement the monitoring and verification procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm failed to document any of the monitoring or verification procedures required by your HACCP plan for the control of histamine development in the scombrotoxin species of fish that you process.

3. You must maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm does not maintain sanitation monitoring records for the eight areas of sanitation required for the processing of your fresh and pasteurized crabmeat and vacuum-packed smoked salmon.

The sanitation deficiencies are as follows:

• Safety of water that comes into contact with food or food surfaces.

• 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 with contaminants.

• Proper labeling, storage and use of toxic chemicals;

• Control of employee health conditions that could result in microbiological contamination.

• Exclusion of pest from the facility.

We are in receipt of your response dated February 24, 2008 to our letter issued September 28, 2007. Your response did not adequately address the significant violations outlined in the September 28, 2007 letter. Most of the violations outlined previously are the subject of this letter.

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 Karen Y. Dodson, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mrs. Dodson at (404) 253-1299.

Sincerely,

/S/

Mary H. Woleske, Director
Atlanta District