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  5. IL Pastaio, Inc. - 10/10/2014
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IL Pastaio, Inc.

IL Pastaio, Inc.

United States

Issuing Office:
San Francisco District Office

United States


Department of Health and Human Services logoDepartment 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


October 10, 2014
Francesco Avella, President
Il Pastaio, Inc.
1266 East Julian Street
San Jose, CA 95116
Dear Mr. Avella:
We inspected your seafood processing facility located at 1266 East Julian Street, San Jose, CA between the following dates:  August 25 to August 26, 2014.  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 seafood products, including frozen Lobster Ravioli, containing lobster and shrimp, and Smoked Salmon Ravioli, 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 are as follows:
You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control the 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 frozen seafood ravioli products, including those containing lobster and shrimp and smoked salmon, to control the food safety hazards of pathogens and potential toxin formation and undeclared allergens.
Once you have conducted a hazard analysis for your 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 to comply with 21 CFR 123.6(c).  
Please refer to the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition (the Hazards Guide), includingChapter 12 (Pathogenic Bacteria Growth and Toxin Formation as a Result of Time and Temperature Abuse), Chapter 16 (Pathogenic Bacteria Survival Through Cooking or Pasteurization), and Chapter 19 (Undeclared Major Food Allergens)for guidance in determining the appropriate controls for your processing operations.
We may take further action if you do not promptly correct these violations.  For instance, we may seize your product(s) and/or enjoin your firm from operating. 
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 noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved.  Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).  For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility.  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 costs.
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 copies of your HACCP plan(s), at least five (5) product days worth of HACCP monitoring records to demonstrate that you have implemented the revised plans, any verification records, and other useful information that would assist us in evaluating your corrections, such as your hazards analysis.  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 attention:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference the CMS number 441611 in your response.
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
Kathleen M. Lewis, JD
San Francisco District Director
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