Inspections, Compliance, Enforcement, and Criminal Investigations
Sunset Deli 12-Jul-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
July 12, 2001
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTEDIn reply refer to Warning Letter SEA 01-69
Michelle Y. Lee, Owner
402 Martin Luther King Jr. Blvd.
Portland, Oregon 97214
Dear Mr. Lee:
We inspected your firm located at Martin Luther King Jr. Blvd., Portland, Oregon, on May 29, 2001, and found that you have serious deviations from Title 21 of the Code of Federal Regulations (21 CFR) Part 123- Fish and Fishery Products (Seafood HACCP regulations). A FDA 483 form (copy enclosed) listing the deviations was presented to you at the conclusion of the inspection. These deviations, some of which were previously brought to your attention, cause your tuna salad sandwiches to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the Seafood HACCP regulations through links in FDA?s homepage at www.fda.gov.
The deviations were as follows:
1.You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). Your firm does not have a HACCP plan for tuna salad sandwiches to control the food safety hazards of allergens and pathogens.
2.You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). In addition, you must have sanitation control records that document monitoring and corrections, to comply with 21 CFR 123.11(c). Your firm did not monitor sanitation or maintain sanitation control records. The records are required to document the following eight sanitation elements: .
- Safety of process water
- Condition and cleanliness of food contact surfaces
- Prevention of cross-contamination
- Maintenance of hand washing, hand sanitizing, and toilet facilities
- Protection of food, food packaging and food contact surfaces from chemical, physical and biological hazards
- Proper labeling, storage and use of toxic compounds
- Control of employee health conditions
- Exclusion of pests from the food plant
For your information, these issues were brought to your attention in a letter dated May 5,2000. You did not respond to this letter, nor have you made any corrections. This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, and the Good Manufacturing Practice regulations (21 CFR Part 11O). You also have a responsibility to use procedures to prevent further violations of the Federal Food Drug, and Cosmetic Act and all applicable regulations. 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.
Please respond in writing within three (3) weeks from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as your revised HACCP plan and copies of your monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Lisa Elrand at (425) 483-4913.
Charles M. Breen
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