Inspections, Compliance, Enforcement, and Criminal Investigations
James Hook & Co., LLC 09-Dec-03
Department of Health and Human Services |
Public Health Service |
New England District |
WARNING LETTER
NWE-09-04W
VIA FEDERAL EXPRESS
December 9, 2003
Alfred A. Hook
Owner
James Hook & Co., LLC
15-17 Northern Avenue
Boston, MA 02210
Dear Mr. Hook:
We inspected your seafood processing facility, James Hook & Co., located
at 15-17 Northern Avenue, Boston, MA, on November 5, 6, 12, and 18, 2003. We
found that you have a serious deviation from the Seafood Hazard Analysis and
Critical Control Point (HACCP) regulations, Title 21 Code of Federal Regulations,
Part 123 (21 CFR 123). In accordance with 21 CFR 123.6 (g), failure of a processor
to have and implement a HACCP plan that complies with this section or otherwise
operate in accordance with the requirements of this part, renders the fishery
products processed there 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 lobstermeat is adulterated, in
that the product has been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or whereby it may have been
rendered injurious to health. You may find the Act and the seafood HACCP
regulations through links in FDAs home page at www.fda.gov.
The serious deviation observed was as follows:
1. You must conduct a hazard analysis to determine whether there are food safety
hazards that are reasonably likely to occur and you must have 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 refiiperated, ready-to-eat lobstermeat you routinely manufacture at
this location.
We may take further action if you do not promptly correct this above violation.
For instance, we may take further action to seize your product(s) and/or enjoin
your firm from operating.
Please 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 this deviation. You should include in your response any documentation, such as your HACCP plan, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deficiencies.
This letter may not list all the deviations at your facility. Yoy are responsible
for ensuring that your processing plant operates in compliance with the Act,
the Seafood HACCP regulations and the Good Manufacturing Practice regulations
(21 CFR Part 110). You also have a responsibility to use procedures to prevent
further violations of the Federal Food, Drug, and Cosmetic Act and all applicable
regulations.
You may direct your reply to Karen N. Archdeacon, Compliance Officer, at the
address noted above. If you have any questions concerning this matter, please
contact Ms. Archdeacon at (781) 596-7707.
Sincerely,
/s/
Michael Kravchuk for Gail T. Costello
District Director
New England District Office