- MGH Gourmet, Inc.dba Gourmet Foods, Inc.
- Issuing Office:
- San Francisco District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
RETURN RECEIPT REQUESTED
March 18, 2016
Heinz Naef, President and Owner
MGH Gourmet Inc., dba Gourmet Foods Inc.
2910 Harcourt Street
Rancho Dominguez, CA 90221
Dear Mr. Heinz Naef:
We inspected your seafood processing facility, located at 2557 Barrington Court, Hayward, CA 94545 on 10/27, 10/28, 10/30/2015, 11/5, 11/16/2015. We found that you have serious violations from the FDA's 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 of Federal Regulations, Part 110 (21 CFR Part 123 & 110). In accordance with 21 CFR Part 123.6(g), HACCP plan that complies with 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 the section 402(a) 4 of the Federal Food, drug and Cosmetic Act (the Act) [U. S. C. § 342(a) (4)]. Accordingly, your crab cakes, smoked salmon, lobster, shrimp, scallop, smoked trout, and ahi tuna canapés seafood 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 Federal Food, drug and Cosmetic Act (ACT), the Seafood HACCP regulation and the Fish and Fishery Products Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov
Your significant violations were as follow:
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 canned frozen fish roe to control for the food safety hazard Clostridium botulinum.
2. 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(b) as a point, step, or procedure in a food process at which control can be applied and the food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels. However your firm’s HACCP plans that include canned crab, smoked salmon, and ahi tuna titled Raw - Ready-to-Cook, (R-RTC), Ready-to- Eat, (RTE), and Cooked, Ready-to-Eat, (C-RTE) do not list the critical control points of thawing the frozen canned crab, frozen blocks of ahi tuna and frozen vacuum packaged smoked salmon for controlling the food safety hazards of pathogenic bacteria growth and toxin formation.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products 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 that you are doing to correct these violations. You may wish to 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 stated when you will correct any remaining violations.
Section 743 of the Act [21 U.S.C § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-inspection fees [21 U.S.C § 379j-31(a)(2)(B)]. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related cost.
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 FD&C Act, and the seafood HACCP regulation (21 CFR Part 123) and 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 reply to the Food and Drug Administration,
Lawton W. Lum,
Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference CMS # 107332
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-6737.
Kathleen M. Lewis, JD