|Company:||Scariano Brothers, LLC|
|Subject:||Seafood HACCP/CGMP for Foods/Adulterated|
|Issuer:||New Orleans District Office|
|Issued:||April 26, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
New Orleans District
April 26, 2012
WARNING LETTER NO. 2012-NOL-18
UNITED PARCEL SERVICE
Delivery Signature Requested
Jack J. Scariano, President/Co-Owner
Scariano Brothers, LLC
11052 Scariano Lane
Hammond, Louisiana 70401
Dear Mr. Scariano:
On January 17-18, 2012, an investigator with the U.S. Food and Drug Administration (FDA) inspected your facility, located at 11052 Scariano Lane, Hammond, Louisiana. The inspection found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations , Part 123 (21 CFR 123), and the Current Good Manufacturing Practice regulation for foods, 21 CFR 110. In accordance with 21 CFR 123.6(g) failure of a processor of fish or fishery product to have and implement a HACCP plan which 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 United States Code (USC) 342(a)(4)]. Accordingly, your PBC Pasteurized Jumbo Lump, one pound; eight ounce Blue Pasteurized Crab Lump; PBC Pasteurized Claw Meat, one pound; eight ounce Blue Pasteurized Crab Claw Meat; and, eight ounce Pasteurized Special Crab Meat 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 .
On January 18, 2012, a FORM FDA 483, Inspectional Observations (FDA 483), was issued to Ronald C. Bentin, Operations Manager. This FDA 483 is enclosed for your records. The significant violations listed include the following:
1. Failure to conduct, or have conducted, a hazard analysis to determine whether there are food safety hazards which are reasonably likely to occur for each kind of fish and fishery product you process [21 CFR 123.6(a)]. You must conduct or have conducted a hazard analysis for each kind of fishery product which you produce/store to determine whether there are food safety hazards which are reasonably likely to occur.
2. Failure to have a written HACCP plan which outlines controls for a food safety hazard that is reasonably likely to occur [21 CFR 123.6(b)]. You should have a HACCP plan in place for each type of seafood product held at your facility.
3. Failure for an employee, or someone associated with your firm, to complete the required HACCP training or to be HACCP certified through job experience (21 CFR 123.10).
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.
Please note FDA has recently published a 4 th Edition of the “ Fish and Fisheries Products Hazards and Controls Guidance ”. This provides the most current information to assist processors in developing their HACCP plans.
You are required to monitor sanitation conditions and practices during processing, which includes warehousing activities, with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, 123.11(b).
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 costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection which has identified non-compliance 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 USC 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct this violation. You should include in your response documentation such as HACCP plans for each of your seafood products; hazard analyses for each species of seafood products you process; and any procedures/documentation of HACCP training and related sanitation records. 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 Current Good Manufacturing Practice regulation (21 CFR 110). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Kari L. Batey, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.
Patricia K. Schafer
New Orleans District