Inspections, Compliance, Enforcement, and Criminal Investigations
Italfoods, Inc. 5/1/07
Department of Health and Human Services
|Public Health Service |
Food and Drug Administration
|San Francisco District |
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: 3002306825
May 1, 2007
Georgette A. Guerra, President
205 Shaw Road
South San Francisco, California 94080
Dear Ms. Guerra:
We inspected your seafood processing facility, ltalfoods, Inc., located at 205 Shaw Road, South San Francisco, California., on March 12, 15, and 16, 2007. 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 this part, 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 refrigerated, ready-to-eat fish and fishery products including [redacted] are adulterated in that the products have been prepared, packed, or held under insanitary conditions whereby they may have been r 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 foods safety hazards that are reasonably likely to occur; to comply with 21 CFR Part 123.6(a) and (b). However, your firm does not have HACCP plans for refrigerated, ready-to-eat fish and fishery products such as [redacted] control histamine formation; [redacted] to control pathogen growth and toxin formation including Clostridium botulinum toxin in vacuum packaged fish and fishery products.
(2) You must monitor sanitation conditions and practices during processing with sufficient frequency, and maintain sanitation control records that document the monitoring and corrections, to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b) and (c). However, your firm is not monitoring and documenting the eight areas of sanitation to ensure control of:
a. Safety of water;
b. Condition and cleanliness of food contact surfaces;
c. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces;
d. Maintenance of hand washing, hand sanitizing, and toilet facilities;
e. Protection of food, food packaging material, and food contact surfaces from adulteration with chemical, physical, and biological contaminants;
f. Proper labeling, storage, and use of toxic compounds;
g. Control of employee health conditions; and
h. Exclusion of pests from the food plant.
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) or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days of 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 establishment 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Ms. Erlinda N. Figueroa, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District