Inspections, Compliance, Enforcement, and Criminal Investigations
Domestic Cheese Company, Inc. 14-May-07
Department of Health and Human Services
Public Health Service
San Francisco District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: FEI 2910638
May 14, 2007
Robert Stoops, President
Domestic Cheese Company, Inc.
450 Toland Street
San Francisco, California 94124
Dear Mr. Stoops:
We inspected your seafood processing facility, located at 450 Toland Street, San Francisco, California on February 8, 14, and 15, 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 114 (21 CFR 123 and 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 refrigerated, ready-to-eat, smoked [redacted] and [redacted] and [redacted] products 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 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 for human consumption. However, your firm's HACCP plan for "Refrigerated Marinated [redacted]" does not list the food safety hazard of pathogen growth and toxin formation as a result of time/temperature abuse.
2) You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plans for "Vacuum Packed [redacted]" and "Refrigerated Marinated" [redacted] list critical limits "Surface temperature of packaged product not to exceed [redacted] degrees F" and "Surface temperature of package not to exceed [redacted] degrees F" respectively, at the Receiving critical control points that are not adequate to control histamine in marinated anchovies, and pathogens including Clostridium botulinum toxin formation in the vacuum packaged products. Specifically, the critical limits are inadequate because they are incomplete. While taking product temperatures at receipt is adequate for short transit times, you receive product that is in transit for both extended and relatively short periods of time. Consequently, transit time will need to be taken into consideration as an element to be controlled. Moreover, monitoring procedures for those products held in transit for extended periods will need assurances that proper temperatures were continuously maintained throughout transit. Consequently, the critical limit and monitoring procedures should be modified accordingly to reflect both situations.
3) You must implement the monitoring procedures and frequency 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 any of the monitoring procedures listed in your HACCP plans. For example, you do not "read and record" cooler temperatures as listed at the Storage critical control points in both plans.
4) 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 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 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
cc: Robert J. Morbidelli, Director of Purchasing and Quality Control