Inspections, Compliance, Enforcement, and Criminal Investigations
Poseidon Enterprises, Inc. 04-Mar-05
Department of Health and Human Services
Public Health Service
Atlanta District Office
March 4, 2005
VIA FEDERAL EXPRESS
Richard Lavecchia, President
Poseidon Enterprises, Inc.
3515 Green Park Circle
Charlotte, NC 28217
Dear Mr. Lavecchia:
On January 10-11, 2005, FDA conducted an inspection of your seafood processing facility located at 7424 ACC Blvd., Suite 103, Raleigh, North Carolina. During that inspection, our investigator documented serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). 1n accordance with 21 CFR 123 .6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or to otherwise operate in accordance with the requirements of 21 CFR Part 123, renders the 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 fresh, histamine-forming fish, fresh and pasteurized crabmeat, smoked fish products, and assorted seafood spreads are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health . You may find the Act and the seafood HACCP regulations through links in FDA's home page at www.fda.gov.
The deviations of concern are as follows:
1) You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and 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 pasteurized crabmeat to control the food safety hazard of pathogen growth and toxin formation as a result of time/temperature abuse.
2) You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.b(b). However, your firm did not:
follow the monitoring frequency of continuous monitoring of the cooler temperature at the "Cooler Storage" critical control point (CCP) to control the histamine formation and/or pathogen growth hazards listed in your HACCP plans for fresh histamine prone (scombroid) fish, fresh crabmeat, smoked fish products, and refrigerated assorted seafood spreads. Your record the cooler temperature [redacted] times a day, but there is no monitoring on [redacted]. In view of the absence of a continuous temperature recording/monitoring system, even with [redacted] daily temperature readings obtained [redacted] your failure to monitor the cooler temperature on [redacted] renders your efforts insufficient to control the specified hazard(s).
follow the monitoring procedure of checking the product temperature with a dial thermometer for each lot of incoming smoked fish at the "Receiving" CCP to control the pathogen growth and Clostrrdium botulinum hazards.
check the product's internal temperature with a dial thermometer for each incoming lot of assorted seafood spreads at the "Receiving" CCP to control the hazard of pathogen growth.
3) You must have a HACCP plan that, ax a minimum, lists the critical limits that must be met at each of the critical control points, to comply with 21 CFR 123.6(c)(3) . A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for assorted seafood spreads lists critical limits at the "Receiving" and "Cooler Storage' CCPs, i.e., "Internal temp. of product not to exceed [redacted] degrees" and "Cooler temp. not to exceed [redacted] degrees" that are not adequate to control the pathogen growth hazard .
4) Because your HACCP plan includes corrective actions, the described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans included in your HACCP plans for fresh histanline prone (scombroid) fish, fresh crabmeat, smoked fish products, and refrigerated assorted (seafood) spreads at the "Cooler Storage" CCP are not appropriate to control the specified hazards. Specifically, the listed corrective actions fail to include an evaluation of the seafood product stored in the cooler at the time the critical limit was exceeded, to determine its suitability for distribution.
This letter may not list all the deviations at your facility. You 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 farther violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations . For instance, we may recommend that the United States bring a legal action to seize your product(s) and/or enjoin your firm from operating.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation, such as copies of HACCP plans and HACCP monitoring records, 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 deviations.
Please send your reply to Carlos A. Bonnin, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mr. Bonnin at 404-253-1277.
Mary H. Woleske, Director