Inspections, Compliance, Enforcement, and Criminal Investigations
Gulfish LP 1/4/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: FEI 3009222439
January 4, 2012
James S. Galle, Owner
P. O Box 2795
Sausalito, California 94966
Dear Mr. Galle:
We inspected your seafood processing facility, located at 1970 Innes Avenue, San Francisco, California on November 7 and 8, 2011. 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 (21 CFR 123). 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 refrigerated, scombrotoxin-forming fish, e.g., Almaco Jack (aka Kampachi), Escolar, and Barracuda, and your refrigerated, ready-to-eat fish and fishery products, e.g., cooked blue crabmeat 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 fresh chilled scombrotoxin-forming fish, e.g., Almaco Jack (aka Kampachi), Escolar, and Barracuda to control histamine formation as a result of time/temperature abuse during the receipt and storage of the product.
(2) 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe fro human consumption.” However, your firm’s HACCP plan for “Packaged Cooked Crab” does not list the food safety hazard of pathogen growth and toxin formation in refrigerated, ready-to-eat, packaged crabmeat. This deviation was noted upon further review of your HACCP plan dated 11/7/11. Although your Hazard Analysis Worksheet has identified correctly the significant hazard of pathogen growth that is likely to occur in your refrigerated, ready-to-eat, cooked crab, you did not carry it over into your HACCP plan.
(3) You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a)( and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for “Packaged Cooked Crab” does not list the critical control points of Receiving and Cooler Storage for controlling pathogen growth and toxin formation in refrigerated, ready-to-eat cooked crab. To establish the appropriate critical limits, monitoring procedures, corrective actions, verification, and record-keeping system, please refer to Chapter 12 of the HACCP Guide, 4th Edition.
(4) You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring of the temperature at a frequency of (b)(4) at the Temperature critical control point to control the hazards listed in your HACCP plan for “Packaged Cooked Crab.”
(5) You must monitor sanitation conditions and practices during processing with sufficient frequency, and maintain sanitation control records that, at a minimum, document 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 sanitation conditions of the following areas of sanitation:
a) Safety of 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;
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;
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) and/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 processing plant operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). 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: Darlene B. Almogela, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District