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WARNING LETTER

Nathan's Soup & Salad Henrietta Inc. MARCS-CMS 538526 —


Delivery Method:
UPS

Recipient:
Recipient Name
Richard M. Torcello
Nathan's Soup & Salad Henrietta Inc.

900 Jefferson Rd. BLDG 3

Rochester, NY 14623
United States

Issuing Office:
New York District Office

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations East – Division 1 
 
 

 

WARNING LETTER
CMS # 538526
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
October 11, 2017
 
Mr. Richard M. Torcello, Owner
Nathan’s Soup and Salad Henrietta Inc.
900 Jefferson Rd. BLDG 3
Rochester, NY 14623
 
Dear Mr. Torcello:
 
The United States Food and Drug Administration (FDA) inspected your soups and Ready-to-Eat (RTE) salads manufacturing facility, located at 900 Jefferson Road, Building 3, Rochester, NY 14623 between August 21st, 2017 and August 25th, 2017. During the inspection, our FDA investigator observed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 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 refrigerated, New England Clam Chowder is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 violation is 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 refrigerated New England Clam Chowder to control the food safety hazards of pathogen growth, pathogen survival through cooking or pasteurization and toxin formation including Clostridium botulinum due to time/temperature abuse. 
 
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR Part 110) and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
 
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 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 re-inspection-related costs.
 
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
 
Please send your reply to the Food and Drug Administration, Attention: W. Martin Rennells, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contactW. Martin Rennellsat 518-453-2314 x1038 or william.rennells@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1