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WARNING LETTER

D’Andrea Foods Inc. MARCS-CMS 576292 —

Product:
Food & Beverages
Seafood/Seafood Product

Recipient:
Recipient Name
Mr. Michael D’Andrea
Recipient Title
President and Owner
D’Andrea Foods Inc.

378 Pleasant Street
East Bridgewater, MA 02333-1349
United States

Issuing Office:
Division of Human and Animal Food Operations East I

158-15 Liberty Avenue
Jamaica, NY 11433
United States


WARNING LETTER

CMS # 576292

 

VIA UNITED PARCEL SERVICE

DELIVERY SIGNATURE REQUIRED

 

March 15, 2019 

 

Mr. Michael D’Andrea, President and Owner

D’Andrea Foods Inc.

378 Pleasant Street

East Bridgewater, MA 02333-1349

 

Dear Mr. D’Andrea:

The United States Food and Drug Administration (FDA) inspected your seafood warehouse and distribution facility, located at 378 Pleasant Street, East Bridgewater, MA 02333-1349, on February 11 and 15, 2019. We found that you have a serious violation 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 refrigerated, ready-to-eat (rRTE) seafood salads and tuna salads are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay 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:

  • 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 an 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: 

1.      rRTE seafood salads to control the food safety hazard of pathogenic bacteria growth and toxin formation; and

2.      rRTE tuna salads to control the food safety hazard of pathogenic bacteria growth and toxin formation and scombrotoxin (histamine) formation.

We acknowledge receipt of a response from your firm on March 5, 2019, responding to the Form FDA-483, Inspectional Observations, issued to your firm on February 15, 2019. Your firm’s response is inadequate because you did not provide any information that indicates you have conducted a hazard analysis and implemented an adequate HACCP plan for your rRTE seafood salads and tuna salads. 

It is our expectation that once a hazard analysis has been conducted for your seafood products, your HACCP plan must, at a minimum, list the hazards that are reasonably likely to occur and include appropriate critical control points, critical limits, monitoring procedures and frequencies, verification procedures and frequencies, and provide for a recordkeeping system. Please refer to the Fish and Fishery Products Hazards and Controls Guidance: Fourth Edition, including Chapter 7 (Scombrotoxin (Histamine) Formation) and Chapter 12 (Pathogenic Bacterial Growth and Toxin Formation as a Result of Time and Temperature Abuse), for guidance in determining the appropriate controls for your operations.

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You should take prompt action to correct the violation cited in this letter. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations, including the seafood HACCP regulation (21 CFR 123). You also have a responsibility to prevent further violations of the Act and all applicable regulations.

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.

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 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. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the U.S. Food and Drug Administration, Attention: Timothy M. Glod, Compliance Officer, 1 Montvale Avenue, 4th Floor, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Glod at (781) 587-7473 or by email at Timothy.Glod@fda.hhs.gov.

 

Sincerely,

/S/

Ronald Pace

Program Division Director

Office of Human and Animal Food Operations East – Division 1