Inspections, Compliance, Enforcement, and Criminal Investigations
Center Oriental Food 06-Aug-08
Department of Health and Human Services
Public Health Service
August 6, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-29
Young C. Song, Owner
Center Oriental Food
9641 15th Avenue SW
Seattle, Washington 98106
Dear Ms. Song:
We inspected your food and seafood processing facility, located at 9641 15th Avenue SW, Seattle, Washington, on May 13 and 15, 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 seasoned dried anchovy is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it 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 for each kind of fish and fishery product that-you produce 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 seasoned dried anchovy to control the food safety hazards of pathogen growth, potential toxin production, and undeclared food allergens, specifically wheat. Your hazard analysis should address those steps that may lead to pathogen growth and potential toxin formation as a result of time and temperature abuse, and appropriate controls should be included in your plan. With regard to the hazard posed by undeclared wheat as a potential food allergen, the hazard can be controlled by including a critical control point in your HACCP plan to monitor each lot of finished product labels to ensure that wheat is listed in the ingredient statement.
For more information on the hazard of pathogen growth and toxin formation, please refer to Chapters 12, 13, and 15 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazard Guide). For more information on the hazard of allergens/food intolerances, please refer to Chapter 19 of the Hazard Guide.
2. 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 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; maintenance of hand washing and hand sanitizing facilities; and 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, for example, by:
a. The hand washing sink being inaccessible due to the brining, barrels that were blocking the pathway to the sink. This makes it difficult for employees to access the sink to wash and sanitize their soiled hands or gloves. This violates 21 CFR 123.11 (b)(4).
b. A fly observed in the processing area due to an unscreened entrance door and opening at the base of the double door leading to the outside, measuring at least 1/4 of an inch. The bottom of the double door also had a larger opening at least four inches long and two inches high, providing a potential entryway for pests. This violates 21 CFR 123.11(b)(8).
3. 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 did not maintain sanitation monitoring records for safety of the water that comes into contact with the food or food contact surfaces; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects to food, food packaging material, and other contact surfaces; maintenance of hand washing, hand sanitizing, and toilet facilities; 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; proper labeling, storage, and use of toxic compounds; control of employee health conditions that could result in microbiological contamination; and exclusion of pests from the food plant, required for the processing of seasoned dry anchovies.
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 written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23d Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen
Copy of FDA 483
cc: WSDA, with disclosure statement