| Public Health Service Food and Drug Administration |
New England District |
Department of Health and Human Services
WARNING LETTER
NWE-11-11W
VIA UPS Next Day Air
February 28, 2011
Mr. Kenneth Haslam
President
Newport Lobster Company, Inc.
1076 Aquidneck Avenue
Middletown, RI 02842-5204
Dear Mr. Haslam:
We inspected your seafood processing establishment, located at 1076 Aquidneck Avenue, Middletown, RI on November 23 through December 15, 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).
Accordingly, your ready-to-eat cooked lobster meat products, tuna and pasteurized 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 through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the routine cooking of lobster meat or the presence of ice twice daily at the cooler storage critical control point to control pathogens listed in your HACCP plan for RTE cooked lobster meat, RTE pasteurized crabmeat, and raw tuna. For example:
a. Your firm had no monitoring records for the routine cooking of lobster meat at your facility. Your HACCP plan indicates that records will be completed to assure that the cooking critical limits (CL’s) are met, yet you indicated that these records are not maintained.
b. HACCP plans for three of your high risk seafood products, ready to eat (RTE) cooked lobster meat, RTE pasteurized crabmeat and raw tuna, all indicate that you will monitor the presence of ice twice daily at the cooler storage critical control point (CCP). During the inspection we observed that you were not recording this data twice a day. We also observed a number of days that had no monitoring data for this CCP.
c. HACCP plans for two of your high risk seafood products, RTE pasteurized crabmeat and raw tuna, indicate that you will monitor presence of ice or cooling medium for RTE pasteurized crabmeat and the presence of ice and temperatures for raw tuna at the receiving step of these products. Your firm had no monitoring records for the receiving of these products at your facility.
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for RTE pasteurized crabmeat and raw tuna at the “Cold Storage/Holding” critical control point are not appropriate. The corrective actions for the critical control points of these products lists “ICE DOWN & MONITOR,” “EVALUATE PRODUCT SAFETY,” and “CORRECT CAUSE OF ANY PROBLEM.” Your corrective action plans do not list how you intend to correct the cause of the deviation, for example by discontinuing the use of the suppliers.
In addition, none of your corrective actions list measures to ensure that potentially adulterated products do not enter into commerce. For example your corrective action plans do not reference product disposition when products are found to have exceeded the critical limits.
3. Failure to maintain sanitation control records which, at a minimum, document the monitoring and correction of eight key sanitation principles, as required by 21 CFR 123.11(c). Your firm did not have any monitoring data for the months of January, February, March, April, May, June, July, August, October and November 2010 that included the monitoring data of the following eight sanitation principles:
a. Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;
b. Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
c. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;
d. Maintenance of hand washing, hand sanitizing, and toilet facilities;
e. Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological compounds;
f. Proper labeling, storage, and use of toxic compounds;
g. Control of employee health conditions that could result in the microbiological contamination of food, food packaging material, and food contact surfaces; and
h. Exclusion of Pests from the food plant.
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 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.
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: Karen N. Archdeacon, Compliance Officer, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District
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