Source: https://www.fdalabelcompliance.com/letters/ucm241217
Timestamp: 2020-08-06 15:29:44
Document Index: 172838108

Matched Legal Cases: ['art 123', 'art 123', 'art 110', 'art 110', 'art 123', '§ 342']

Company: D. Brickman Inc
Issuer: New York District Office
Issued: Jan. 18, 2011 Closed: July 21, 2011
Source ucm241217 Archive Code:
D. Brickman Inc 1/18/11
WARNING LETTER NYK-2011-15
James P. Hans, Owner
We inspected your seafood processing establishment, located at 2 D. Brickman Inc. 381 Broadway, Menands Market, Albany, New York 12204 between October 28 and November 5, 2010. 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 Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 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).
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, at a minimum, 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). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption."
However your firm does not have a HACCP plan for tuna and mahi mahi to control the food safety hazard of scombrotoxin (histamine) formation.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done, since your August 18, 2010 correspondence, 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.
Please send your reply to the Food and Drug Administration, Attention: Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have questions regarding any issues in this letter, please contact Mr. Rugnetta at (716) 541-0324.
D. Brickman Inc - Close Out Letter 7/21/11 [ARCHIVED]