Inspections, Compliance, Enforcement, and Criminal Investigations
Hawk Vending Services, Incorporated 27-Sep-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Seattle District |
22201 23rd Drive SE
Bothell, WA 98021-4421
September 27, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-35
James H. Watson, President/Owner
Hawk Vending Services, Incorporated
1160 Fisher Avenue
Medford, OR 97504
Dear Mr. Watson:
We inspected your seafood processing facility, located at 1160 Fisher Avenue, Medford, Oregon on September 13 and 14, 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 & 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 ready to eat tuna salad sandwiched 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 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 (b). However your firm does not have a HACCP plan for the ready to eat tuna salad sandwiches that you store and distribute refrigerated to control the food safety hazard of pathogen growth and toxin production.
2. 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 has never maintained sanitation monitoring records required for the processing of tuna salad sandwiches for the following sanitation elements:
a. Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;
b. Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
c. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;
d. Maintenance of hand washing, hand sanitizing, and toilet facilities;
e. Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;
f. Proper labeling, storage, and use of toxic compounds;
g. Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
h. Exclusion of pests from the food plant.
In addition, you must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor exclusion of pests from the food plant with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by two of the loading dock doors leading to the outside that were observed to have two inch gaps on the bottom and sides.
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 Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer. If you have questions regarding any issues in this letter, please contact CO Donovan at 425 483-4906.
Charles M. Breen