Inspections, Compliance, Enforcement, and Criminal Investigations
Dreisbach Enterprises Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|1431 Harbor Bay Parkway|
Alameda, CA 94502-7070
November 2, 2010
Our Reference # 3001238823
Ronald T. Dreisbach, President
Dreisbach Enterprises, Inc.
P.O. Box 7509
Oakland, CA 94601
Dear Mr. Dreisbach:
We inspected your seafood processing facility and warehouse located at 125 Salinas Road, Pajaro, CA 95076 on August 13, 20, and 24, 2010. 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 fresh, refrigerated scombrotoxin-forming fish such as Sardines and Mackerel 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, at a minimum, are reasonably likely to occur and have a HACCP plan that 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 “Seafood” for all fresh, refrigerated fish including scombrotoxin-forming fish, such as Sardines and Mackerel, does not list the food safety hazard of Scombrotoxin (Histamine) formation at the Receiving critical control point. Your plan which currently states “Degradation of product” as a hazard is not an acceptable substitute for Scombrotoxin(Histamine). For information related to the hazard of histamines, please refer to Chapter 7 of the Fish and Fisheries Hazards and Controls Guidance: 3rd Edition (the Hazard Guide).
2) You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected, as required by 21 CFR 123.7(a).
Specifically, on at least two occasions, you deviated from your critical limit “(b)(4)” at the RECEIVING CCP. On June 3, 2010, your receiving record for Mackerel documented that its temperature at receipt was (b)(4)ºF, and on July 9, 2010, your receiving record for Sardines documented that its temperature at receipt was (b)(4)ºF. However, you then processed and distributed the products without having taken corrective actions.
3) Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your HACCP plan for “Seafood” at each critical control point to control its significant hazards are not appropriate because they do not ensure that unsafe product does not reach the consumer and they do not resolve how the cause of the deviations will be corrected.
The above list of violations is not intended to be an all-inclusive list of violations at your firm.
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 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 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 Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Juliane Jung-Lau, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Ms. Jung-Lau at (510) 337-6793.
Barbara J. Cassens,
San Francisco District
cc: Carlos R. Vasquez, Warehouse Manager
Dreisbach Enterprises, Inc.
125 Salinas Road
Pajaro, CA 95076