Inspections, Compliance, Enforcement, and Criminal Investigations
Sea Farms Incorporated 27-Aug-07
Department of Health and Human Services
Public Health Service
Baltimore District Office
August 27, 2007
Mr. Ronald T. Sopko, Owner/President
Sea Farms, Incorporated
536 Mill Pond Road
Hudgins, VA 23076-0309
Dear Mr. Sopko:
From July 10 - July 12, 2007 we inspected your seafood processing facility, located at 536 Mill Pond Road, Hudgins, VA. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part, 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 Bluefish and pasteurized crabmeat are adulterated, in that the Bluefish and pasteurized crabmeat have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it 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 FDA investigator provided you with a copy of the FDA 483, Inspectional Observations, which presents their evaluation of your firm's performance regarding various aspects of the HACCP requirements. The deviations were 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 for each kind of fish or fishery product that you process, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However your firm does not have a HACCP plan for Bluefish to control the food safety hazard of histamine, nor for pasteurized crabmeat to control the food safety hazard of pathogen growth and toxin formation [21 CFR 123.6(b)].
2. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) However, your firm did not follow the monitoring procedure of monitoring internal temperature of histamine providing species of fish as a secondary processor to determine if the temperature is 40 degrees F or less at CCP of the storage critical control point to control histamine listed in your HACCP plan for fresh fish [21 CFR 123.6(b)].
3. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring frequency of checking cooler temperature twice daily at the storage critical control point to control histamine listed in your HACCP plan for susceptible fresh fish [21 CFR 123.6(c)(4)].
4. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following eight areas of sanitation with sufficient frequency to ensure control as evidenced by:
a. Safety of Water: You are not monitoring for the safety of water as evidenced by:
i. backflow prevention devices were observed leaking and hoses attached to these devices were not properly stored and were on the floor in the fish cutting and scaling rooms;
ii. no backflow prevention devices were installed on freshwater hoses used for cleaning on the fish unloading dock. Hoses were observed stored on the floor.
b. Conditions and Cleanliness of Food Contact Surfaces; You are not monitoring the conditions of your food contact surfaces, as evidenced by:
i. cutting boards used for filleting and cleaning fish have deep cuts with organic material and cannot be cleaned and sanitized in the fish cutting and scaling room;
ii. fish sorting tables are constructed of unsealed wood, shovels used for placing ice on fish have wooden handles and metal blades, an interior wall of the ice room has loose panels exposing the wall, the ice machine in the ceiling of the loading dock are dirty and contain insects and webbing;
iii. the electric fish hand scaler contains organic build-up and residual scales after cleaning and prior to use in the fish cutting and scaling room;
iv. the fish sorting table contains deep gouges and organic build-up including fish residue and fish scales, the shovel used for placing ice on the fish during operations has a dirty blade and hand grip containing organic build-up, the plastic strip curtains hanging in the doorway of the ice room are dirty and have organic build-up including mold, the scale used to weigh fish during packing operations contains organic build-up and fish scales, the plastic fish baskets used during packing operations are not thoroughly cleaned and sanitized prior to operations and contained residual fish parts, fish scales, and insect webbing in the fish unloading dock;
c. Prevention of Cross Contamination: You are not monitoring for prevention of cross contamination, as evidenced by an employees sorting shell stock oysters to begin to unload fish and pack them in ice with the same gloves used for oysters without washing and sanitizing the gloves prior to use. These same employees were observed to not wash and sanitized their hands or outer garments prior to stating the fish unloading operations.
d. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities: You are not monitoring hand washing and sanitizing facilities, as evidenced by the hand washing sink located in clam packing room is not utilized by employees unloading fresh fish. This sink is dirty and not routinely cleaned.
e. Protection from Adulterants: You are not monitoring for protections from adulterants, as evidenced by:
f. A bin of ice used to place on fish during cutting operations was stored under a refrigeration unit with condensate dripping into the ice and an open waxed container of fish were observed stored under a refrigeration unit in the fish cooler with condensate dripping onto the fish in the fish cutting and scaling room;
g. The ice machine in the ceiling has are as of rust and pooled water that is located directly above the ice pile and the ice room also has condensate d ripping into the ice pile in the fish unloading room.
h. Employee Health Conditions: You are not monitoring the conditions of your employee's health, as evidenced by employees area not screened daily for their health condition prior to beginning work
i. Exclusion of Pests: You are not monitoring for the exclusion of pests, as evidenced by
i. at least a dozen flies were observed in the fish scaling room during processing operations, there are at least one half inch gaps around the loading dock door and side entrance door leading into the fish cutting area, the plastic strip curtains used in the loading area and fish cutting room are broken and dirty, an d the outside premises of the loading dock and fish cutting room contain accumulated litter including old lumber, fish scales drains, and standing water;
ii. crawling insects and webbing were observed in the ice room and the ice machines in the ceiling of the loading dock.
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.
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 HACCP certification, and sanitation 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.
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 further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Randy F. Pack, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issue in this letter, please contact Mr. Pack at 410-779-5417.