| Public Health Service Food and Drug Administration |
Baltimore District Office |
Department of Health and Human Services
FEI: 1120176
WARNING LETTER
CMS# 209394
October 17, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Timothy F. Daniels, Vice President
Old Point Packing, Inc
817 Jefferson Avenue
Newport News, VA 23607-6117
Dear Mr. Daniels:
We inspected your seafood processing facility, located at 817 Jefferson Avenue, Newport News, VA 23607-6117 on June 14, 15, 16 and 17, 2011. 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 Scombrotoxin forming finfish 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 have a HACCP plan that, at a minimum, lists the critical limits that must be met, 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 histamine forming finfish lists critical limits at Receiving from Truck, Receiving from Vessel, and Storage critical control points that are not adequate to control the formation of Scombrotoxin. Specifically, the critical limits of “Internal fish temperatures must be 40oF or below" at the Receiving from truck, Receiving from vessel, and Storage critical control points are not adequate. For Receiving from Truck, FDA recommends that either 1) all lots are accompanied by transportation records showing that fish were held at 40F or below throughout transit or 2) that the fish received are completely surrounded by ice. For additional FDA recommendations, refer to the Fish and Fishery Products Hazards and Controls Guidance, 4th Edition. FDAs recommendations for receipt of fish directly from harvest vessels are found between pages 125-136. Likewise, recommendations for transit controls may be found between pages 137-144, and storage controls are between pages 146-149.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However,
• your firm did not follow the monitoring procedure of “Ice coverage” and “Internal fish temperature” at the Receiving from Vessel critical control point to control Scombrotoxin formation listed in your HACCP plan for histamine forming finfish. Specifically, on 10/14/10, your firm received and packed 2,053 pounds of Boston Mackerel. On 10/15/10, the Boston Mackerel was shipped to Edenton, NC. No internal temperatures of Boston Mackerel in the received lot were taken and the adequacy of ice in the received lot was not verified. Also, on 9/24/10, your firm received and packed two pounds of Bluefish. No internal temperatures of Bluefish in the received lot were taken and the adequacy of ice in the received lot was not verified.
• your firm did not follow the monitoring procedure of “Ice coverage” and “Internal fish temperature” at the Storage critical control point to control Scombrotoxin formation listed in your HACCP plan for histamine forming finfish. Specifically, on the dates between 7/1/10 and 6/14/11, including but not limited to 8/7 – 8/13/10, 9/20 – 9/24/10, 10/9 – 10/15/10, 4/11 – 4/15/11 and 4/23 – 4/29/11 the ice coverage and internal fish temperature of histamine forming finfish was not verified.
3. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a).
• However, your firm did not take a corrective action to control Scombrotoxin formation when your process for histamine forming finfish deviated from your critical limit at the Receiving from Vessel critical control point. Specifically, on 4/26/11, 10 pounds of Bluefish were received. The Bluefish Vessel Report dated 4/26/11 indicates that the Bluefish internal temperatures reached 42o and 44o. The fish were iced, packed and stored for shipment. Also, on 9/28/10, an unknown amount of Bluefish were received. The Bluefish Vessel Report dated 9/28/11 indicates that the Bluefish internal temperatures reached 50o and 49o. The fish were iced, packed and stored for shipment. Your firm was unable to provide any evidence that a corrective action was taken.
In addition, the inspection revealed that:
• Your firm failed to have a written HACCP plan that outlines controls for Environmental Chemicals which is reasonably likely to occur in Croaker and Spot harvested from tidal waters of the Chesapeake Bay. For additional FDA recommendations please refer to Chapter 9 of the Fish and Fishery Products Hazards and Controls Guidance, 4th Edition.
• The Harvest Vessel Records were found inadequate. The Harvest Vessel Records do not provide information such as the time net was set, the air and water temperatures, were the fish harvested in 1 haul back or several, if there were several haul backs, how is one set distinguished from another, and were any of the fish landed dead. Detailed information about the harvest provides the basis for setting critical limits for time and temperature exposures and would ensure that the records provide adequate assurances that fish were, in fact, properly iced and handled on board the vessel.
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.
Your response should be sent to: U.S. Food and Drug Administration, Attention: Evelyn Bonnin, District Director, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. Refer to the Unique Identification Number (CMS # 209394) when replying. If you have questions regarding any issues in this letter, please contact Ms. Kristy Leslie at (757) 483-7042.
Sincerely,
/s/
Evelyn Bonnin
District Director
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