Inspections, Compliance, Enforcement, and Criminal Investigations
September Enterprises, Inc. 06-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Minneapolis District Office |
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 75-7114
FAX: (612) 334-4142
October 6; 2005
RETURN RECEIPT REQUESTED
Refer to MIN 06-01
September Enterprises, Inc.
2010 E. Hennepin Avenue, Suite 8
Minneapolis, MN 55413-1743
Dear Mr. Hazlett and Ms. Tran:
We inspected your seafood processing facility, located at 2010 E. Hennepin Avenue, Suite 8, Minneapolis, Minnesota, on September 7-9, 2005. 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 Curried Tuna-Currants Coconut and Lime Wrap, Tuna with. Dill on Croissant, and Tuna with Dill and Cucumber on Bread sandwiches 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:
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 any critical control point to control pathogen growth and toxin formation listed in your HACCP plan for Tuna Salad Sandwiches. Specifically, you have a HACCP plan for a discontinued Tuna Salad sandwich product and have not re-implemented any monitoring requirements identified in that plan since you began production of your newly acquired Tuna Salad sandwich products.
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 Tuna Salad sandwich products lists a monitoring procedure/ frequency at the cooler storage critical control point that is not adequate to control pathogen growth and toxin formation. Specifically, you reported to our investigator that you check the temperature of your coolers at least [redacted] daily during production. However, checking the temperature [redacted] daily leaves a gap of several hours between temperature checks and no monitoring of the overnight storage of tuna salad and finished tuna salad sandwiches. 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.
You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following: safety of water that comes into contact with food or food contact 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; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110 as evidenced by complete lack of any monitoring records.
We may take further action if you do not promptly correct these violations. For instance, we may take: further action to seize your products 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