Company: A. Tarantino and Sons, Inc.
Subject: Seafood HACCP/CGMP for Foods/Adulterated
Issuer: San Francisco District Office
Issued: Aug. 25, 2008 Closed:
Not applicable.
Source ucm1048165 Archive Code:

A. Tarantino and Sons, Inc. 25-Aug-08

Department of Health and Human Services

Public Health Service
Food and Drug Administration

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


August 25, 2008

Via Federal Express

Our Reference: 1000161244

Anthony J. Tarantino, President
A. Tarantino and Sons, Inc.
2275 Jennings Street
San Francisco, CA 94124

Dear Mr. Tarantino:

We inspected your seafood processing facility, located at 2275 Jennings Street, San Francisco, California, on April 3 and 8, 2008. 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 refrigerated canned wild crabmeat, vacuum packed smoked salmon, vacuum packed smoked trout and histamine-forming fishery 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 .

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 your reduced oxygen packaged seafood products, including but not limited to, refrigerated canned wild crabmeat, refrigerated vacuum packed smoked salmon, and refrigerated vacuum packed smoked trout, to control the food safety hazard of pathogen growth and toxin formation including that of Clostridium botulinum .

Once you have conducted a hazard analysis for refrigerated, reduced oxygen packaged seafood products, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled. For example, your hazard analysis should consider the hazard of pathogen growth and toxin formation, including Clostridium botulinum toxin formation, which is a reasonably likely hazard associated with these products. Preventative measures should be implemented at receipt and during refrigerated storage to ensure that the product is continuously maintained at or below 40° F. For example, upon receipt receiving your firm should consider monitoring the presence of ice or cooling media if product is received on ice or cooling media. Your firm should also consider a means to ensure that adequate storage temperatures are continuously maintained by monitoring the presence of ice or cooling media daily; or monitoring cooler temperatures on a continuous basis.

2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6 (c)(4). However, your firm's HACCP plan for [redacted] lists a monitoring procedure and a frequency at the refrigerated storage CCP that is not adequate to control histamines. Specifically, the HACCP plan for [redacted] lists a monitoring procedure of [redacted] by the [redacted] at a frequency of which is not appropriate to ensure continuous monitoring of your refrigerated fishery products. Intermittent temperature checks as a monitoring procedure during extended refrigerated storage is not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks.

FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we recommend a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly. Alternatively, you may choose to perform a daily visual check of the adequacy of ice or cooling media surrounding product during refrigerated storage; however, your HACCP plan and monitoring records should reflect this monitoring activity accordingly.

3. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for [redacted] at the [redacted] and [redacted] CCPs to control histamine formation are not appropriate. Specially, your corrective action plans do not resolve how the cause of the deviation will be corrected.

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 (2) 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, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Ms. Jung-Lau at 510-337-6193.



Barbara J. Cassens
District Director
San Francisco District