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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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R P Gomes, Inc. 5/27/09

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Central Region

Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone (973) 331-4905


May 27, 2009


WARNING LETTER


09-NWJ-03

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Richard P. Gomes
President/Owner
R P Gomes Inc.
1889 Route 9, Unit 41
Toms River, NJ, 08755

Dear Mr. Gomes:

We inspected your seafood processing facility, located at 1889 Route 9, unit 41 in Toms
River, NJ, from December 10, 2008, through December 16, 2008. 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 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 Ready to Eat Canned
Pasteurized Crabmeat, vacuum packed Smoke Salmon, Ready to Eat Smoked Whitefish
Salad, Fresh Jumbo Lump and Cooked Crabmeat products 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: Third Edition"
through links in FDA's home page at www.fda.gov.

Your significant violations follow:

• You must implement the record keeping system, monitoring procedures and
frequency that you have listed in your HACCP plan, to comply with 21 CFR
123.6(b). Further, your records must contain the actual values and observations
obtained during the monitoring, to comply with 21 CPR 123.6(c)(7). However,
your firm did not follow your monitoring procedures for monitoring product
temperature and/or ice for the fresh temperature products at the "Receiving"
critical control point for "Fresh temperature sensitive products." There were no
temperatures recorded nor observations of the adequacy of ice in your receiving
records for jumbo lump crabmeat, cooked crabmeat and whitefish salad in rigid
containers from January to mid-December 2008. Since you listed temperature
measurement as an option in your HACCP plan, FDA recommends that you either
measure internal temperature or utilize technology that allows you to measure
surface temperature. This is a repeat observation from your last inspection, at
which time you promised to correct this deficiency.

• You must have a HACCP plan that, at a minimum, lists monitoring procedures
and their frequency for each critical control point to ensure compliance with the
critical limits, to comply with 21 CFR 123.6(c)(4). However, your firm's
HACCP plan for "Fresh temperature sensitive products" lists a monitoring
frequency of only "Three times a day; start of day, lunch break and end of day" at
the "refrigerated storage" critical control point. The monitoring frequency
reflected in your HACCP plan is inadequate to control the hazards of pathogen
growth and/or histamine formation. Monitoring of refrigerated storage
temperatures needs to be frequent enough to ascertain if the product/s were
time/temperature abused. FDA's recommendations are available at Table #A-2:
Time/Temperature Guidance for Controlling Pathogen Growth and Toxin
Formation in Seafoods, Appendix 4 in "Fish & Fisheries Products Hazards &
Controls Guidance: Third Edition".

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.

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. please 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.


Your response should be directed to the U.S. Food and Drug Administration, Attention:
Joseph F. McGinnis, Compliance Officer, at the address listed above.

Sincerely,
/S/

Diana Amador-Toro
District Director
New Jersey District