Inspections, Compliance, Enforcement, and Criminal Investigations
Two Brothers Seafood, Inc. 12/5/05
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Juan District Office|
466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
December 5, 2005
RETURN RECEIPT REQUESTED
Mr. Fausto Sanguily Rodriguez
Two Brothers Seafood, Inc.
1600 Jesus T. Pineiro Ave.
Caparra Terrace, San Juan, PR 00922
Dear: Mr. Sanguily
We inspected your seafood processing facility, located at 1600 Jesus T. Pineiro Ave., Caparra Terrace, San Juan, PR 00922 on 9/13, 14, & 21/2005. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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).
Accordingly, your tuna, snapper, mahi-mahi, and halibut are adulterated, in that 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 in FDA's home page at www.fda.gov.
Your significant violations were as follows:
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur as required by 21 CFR 123.6 (b).
No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience as required by 21 CFR 123.10.
Additionally, your firm has violations of current good manufacturing practices as follows:
You are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; condition and cleanliness of food contact surfaces; prevention of cross contamination from insanitary objects; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food packaging materials, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and exclusion of pests as required by 21 CFR 123.11
Failure to provide safety-type lighting fixtures suspended over exposed food as required by 21 CFR 110.20 (b)(5).
We may take further action if you do not promptly correct these violations. Regulatory options to take further action could include seizure of your product(s) and/or enjoining 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 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Carlos I. Medina, at 466 Fernandez Juncos Ave., San Juan, Puerto Rko, 00901. If you have questions regarding any issues in this letter, please contact Carlos I. Medina at 787-474-9539.
David Gao, M.D., Dr. PH, MPH
Acting District Director
San Juan District