Inspections, Compliance, Enforcement, and Criminal Investigations
Lighthouse Marina Partnership
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
Telephone (973) 331-4908
October 15, 2010
RETURN RECEIPT REQUESTED
Mr. Donald Mears, Partner
Lighthouse Marina Partnership
19 West 6th Street
Barnegat Light, NJ 08006
File No. 11-NWJ-01
Dear Mr. Mears:
We inspected your seafood processing facility, located at 16 West 6th Street, Barnegat Light, NJ on May 26 through June 1, 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 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 tuna, bonito, and bluefish 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 monitoring procedures and frequencies that you have listed in your HACCP plan to comply with 21 CFR 123.6(b) and (c)(4). However, your firm failed to follow the monitoring procedures of a) taking internal temperatures on a representative number of fish; b) conducting sensory evaluation of a representative number of fish in the lot, ensuring no more than 2.5% decomposition in the entire lot; and c) obtaining appropriate harvest vessel records at the critical control point of "receive fish from harvest vessel" to control histamine formation listed in your HACCP plan for tuna, bonito, and bluefish.
Specifically, thirteen processing dates between April 1, 2009-May 26, 2010 were reviewed during the inspection and revealed the following:
a. The harvest vessel records obtained by your firm and used to monitor the CCP of "receive fish from harvest vessel" did not include any monitoring for the cooling rate, time cooling began, or adequacy of ice during on-board storage.
b. Of 13 dates of records selected for review, only five dates had receiving records, titled "Lighthouse Marina Harvest Vessel Record," available for review during the inspection. Eight dates had no records. Therefore, there was no assurance that the following critical limits were monitored for those eight dates:
• Internal Temperature of fish
• No more than 2.5% decomposition
• Estimated time of death
• Air and water temperature
• Method of cooling on board the vessel
• Date and time of off-loading
Review of the remaining five receiving records found that sensory evaluation observations, that ensure no more than 2.5% decomposition, were not recorded on four of these five records and the estimated time of death was not recorded on one record. Therefore for thirteen processing dates selected for review, there was evidence that sensory evaluation was monitored on only one of five records, and the estimated time of death was listed on only four of the five records available for review.
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, the corrective action plan in your HACCP plan for tuna, bonito and bluefish, at the critical control point of storage, lists an action that is not appropriate to control scombrotoxin formation. Specifically, your corrective action listed as "add ice" is inappropriate because it does not ensure that adulterated product does not enter commerce.
Your June 14, 2010 response does not address the inappropriate corrective action of adding ice which is listed in your HACCP Plan. Chapter 7 of the Guide recommends histamine testing on a minimum of 60 fish under these conditions. Sensory evaluations are not recommended since they cannot reliably determine the safety of the product.
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, 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: Kerry A. Kurdilla, Compliance Officer at the address listed above. If you have questions regarding any issues in this letter, please contact Ms. Kurdilla at (973) 331-4908
New Jersey District