Inspections, Compliance, Enforcement, and Criminal Investigations
Vincent Piazza, Jr. & Sons Seafood, Inc. 7/6/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
July 6, 2012
WARNING LETTER NO. 2012-NOL-26
UNITED PARCEL SERVICE
Delivery Signature Requested
Vincent Piazza, Jr., President and Owner
Paul R. Piazza, Vice President and Director
Vincent Piazza, Jr. & Sons Seafood, Inc.
1201 Sams A venue
Harahan, Louisiana 70123
Dear Messrs. Piazza:
On February 27-29 and March 1, 2012, U.S. Food and Drug Administration (FDA) investigators inspected your seafood processing facility, located at 1201 Sams Avenue, Harahan, Louisiana. We found 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), and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 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 to comply with this section or otherwise operate in accordance with the requirements of 21 CFR 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), Title 21, United States Code (21 USC), Section 342(a)(4). Accordingly, your seafood products are adulterated, because 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 on FDA's Internet home page at www.fda.gov.
Significant violations were listed on a FORM FDA 483, lnspectional Observations, issued to Mr. Paul R. Piazza on March 1, 2012, and include, but are not limited to, the following:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product you produce to determine whether there are food safety hazards, which are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards, which are reasonably likely to occur, to comply with 21 CFR l23.6(a) and (b). Your firm does not have a HACCP plan for receiving and processing aquacultured salmon, bass, and redfish to control the food safety hazard of use of aquaculture drugs; or, for processing, storing, and distributing vacuum-packaged tuna steaks to control the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation. C. botulinum is reasonably likely to occur during the expected shelf life of your reduced oxygen packaged, tuna steaks under your present practices.
C. botulinum toxin formation would not be reasonably likely to occur and thus would not need to be included in your HACCP plan if actions, such as the following are taken:
a. The product is sealed in packaging material with a final thickness that, at 24°C and one atmosphere of pressure, has an oxygen transmission rate of more than 10,000 cubic centimeters per square meter per 24 hour period of time (10,000 cc/m2/24hr at 24°C and 1 atm);
b. The product is frozen immediately after processing, maintained frozen throughout distribution, and labeled prominently with instructions to keep frozen and to thaw under refrigeration immediately before use (e.g., "Important, Keep Frozen, Thaw Under Refrigeration Immediately Before Use"); or,
c. Alternatively, FDA recognizes the following control as an adequate method of controlling C. botulinum in frozen, vacuum-packaged product, and one you may wish to consider including in your HACCP plan: the product bears a validated time/temperature integrator (TTl), including instructions as to its interpretation, as a monitoring device appropriate for control of C. botulinum toxin formation on each retail or consumer package. A TTI is a device providing a clear indication to the retailer/consumer, by color change or other means, the product may have been exposed to a time and temperature combination which could result in an unsafe product.
2. You must conduct a hazard analysis to determine whether there are food safety hazards which are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control point (CCP), to comply with 21 CFR 123.6(a) and (c) (2). A CCP is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for fish, fillets, and collarbone (scombrotoxin forming tuna, escolar, mahi-mahi, and snapper) does not list the CCP of processing for controlling the food safety hazard of toxin formation.
3. You must implement the monitoring procedures and frequency which you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring the presence of ice on (b)(4) at the "Raw material storage" CCP to control histamine formation listed in your HACCP plan for escolar, tuna, mahi-mahi, and snapper.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each CCP, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for escolar, tuna, mahi-mahi, and snapper lists a monitoring procedure/frequency at the "Raw material storage" CCP which is not adequate to control histamine formation.
Specifically, your HACCP plan lists the monitoring procedure as to determine the presence of ice on (b)(4). You fail to monitor for the presence of ice on your fish at night or over weekends.
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 steps you are taking to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information to 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 your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the CGMP regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 USC 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 there-inspection and assessing and collecting there-inspection fees [21 USC 379j-31(a)(2)(B)]. 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 reinspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 832-1 290, extension 1103.
Patricia K. Schafer
New Orleans District
Enclosure: FORM FDA 483, dated March 1, 2012