Inspections, Compliance, Enforcement, and Criminal Investigations
Zanzibar Cafe, Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4401
RETURN RECEIPT REQUESTED
September 28, 2009
Carole A. Janks, Owner
Zanzibar Cafe Inc.
976 Gamet Ave.
San Diego, CA 92109-2728
Dear Ms. Janks:
We inspected your seafood processing facility, located at 976 Garnet Ave., San Diego, CA 92109-2728 on August 4 and 5, 2009. 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 salads and sandwiches containing tuna 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 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 your firm's ready to eat tuna food products to control the food safety hazard of scombrotoxin (histamine) formation.
2) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CPR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces, the prevention of cross-contamination from insanitary objects to food and other food contact surfaces, maintenance of hand washing and toilet facilities and exclusion of pests from the food plant with sufficient frequency as evidenced by:
a. Rough and stained cutting boards that can contribute to contamination of food products.
b. Food residue and debris on the side of a reach in cooler which appears to be a hand contact area.
c. Greasy food and food debris on hand contact areas of electrical outlet boxes, on the front and rear doors and door handles leading to the production room.
d. At least four flies were observed flying around the production area, and were observed landing on cutting boards, cleaned and stored utensils, produce, and on food.
e. A live cockroach was observed in the production room area.
f. Lack of soap in the men's or women's restrooms and a non-flushing urinal in the men's restroom.
g. Four of four employees working in the production room were not wearing hair nets or other hair covering.
3) You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CPR 123.11(b), to comply with 21 CPR 123.11(c). However, your firm did not maintain sanitation monitoring records for the safety of the water that comes in contact with food or food contact surfaces, including ice; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects to food; maintenance of hand washing, hand sanitation and toilet facilities; protection of food and food contact surfaces from adulteration; proper labeling, storage and use of toxic compounds; control of employee health conditions; and exclusion of pests from the food plant required for the processing of ready to eat tuna food products and/or sanitation corrections records for the above referenced conditions.
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 film from operating.
Additionally, the Food and Drug Administration has determined that your facility is subject to the registration requirement in § 415 of the Act, 21 U.S.C. § 350(d), and our implementing regulation at 21 CPR Part 1, Subpart H. You were advised of this requirement during the August, 2009 Establishment Inspection conducted at your film. The failure to register a facility as required is a prohibited act under § 301(dd) of the Act, 21 U.S.C. § 331(dd). Our records indicate that, to date, this facility has not been registered with FDA.
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 CPR Part 123) and the Current Good Manufacturing Practice regulation (21 CPR Part 110), You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations,
Your response should be sent to:
James P. Stumpff
Acting Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact: Dr. William Vitale, Compliance Officer at 949-608-2919.
Alonza E, Cruse
Cc: Jeff Farrar, DVM, PhD, MPH
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413