New Day Fisheries Inc 8/3/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
August 2, 2012
RETURN RECEIPT REQUESTED
In reply, refer to Warning Letter SEA 12-30
Scott M. Kimmel, Owner and President
New Day Fisheries, Inc.
2427 Washington Street
Port Townsend, Washington 98368-4610
Dear Mr. Kimmel:
We inspected your seafood processing facility, located at 2427 Washington Street, Port Townsend, Washington on June 7-8, 2012.
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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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 whole, cooked Dungeness crab and pickled herring 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 monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b):
a. However, your firm did not monitor for protection of food and food contact surfaces from adulterants as evidenced by condensation dripping from the wooden ceiling and air vents into the processing and packaging area of whole, cooked Dungeness crab and the ingredient preparation area for pickled herring. The ceiling was also observed with insect webbing, peeling paint, and apparent rust and the air vents were observed with dust and apparent rust. Condensation was also observed in the ice storage area. The storage of an in-process tote of ice was observed in the rain outside the facility. [21 CFR 123.11(b)(5)]
b. Your firm did not monitor prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces as evidenced by water splashing from the floor of the facility onto cages of whole, cooked Dungeness crabs and two ice shovels used in the manual crushing and directing of ice, which were stored directly on an iced covered floor frequented by employees. [21 CFR 123.11(b)(3)]
c. Your firm did not monitor the condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments as evidenced by employee handling of raw crab subsequently followed by handling of cooked crab without changing, cleaning, or sanitizing gloves. [21 CFR 123.11(b)(2)]
d. Your firm did not monitor the exclusion of pests from the food plant as evidenced by the presence of rat excreta pellets in the dry storage warehouse, which stores food packaging material, salt, and onions, and gaps leading outside of your facility in several locations. [21 CFR 123.11(b)(8)]
e. Your firm did not monitor the safety of the water that comes in contact with food or food contact surfaces as evidenced by the storage of a potable water hose directly on a wet floor without back flow prevention. [21 CFR 123.11(b)(1)]
We acknowledge your firm’s written response we received following our inspection. A letter, dated June 25, 2012, was received by our office addressing the observations made during the inspection we conducted at your firm. A review of this letter found the response to be partially adequate. Your written response to this observation is partially adequate in that you promised corrections by installing vent fans, repairing the freezer unit on the storage, and conducting employee training. Your written response provided documentation that your firm has hired a contract pest management company and are in the process of addressing gaps throughout the facility. The adequacy of these corrections cannot be verified at this time and will be verified during the next inspection of your firm. However, your written response does not identify how your firm will continue to monitor employee practices and sanitation to prevent future occurrences.
2. You must have a HACCP plan that 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 occurrences of the identified food safety hazard.” However, your firm’s HACCP plan for pickled herring lists a critical limit, “Check temperature on receipt must not be above (b)(4) degrees F” and “No decomposition (persistent and readily perceptible) in (b)(4) containers per shipment,” at the Receiving critical control point that is not adequate to control histamine formation. Because you receive herring cutlets that are transported in excess of 4 hours, and for a period of up to six days, internal temperature checks at receipt and sensory analysis are not considered adequate controls of histamine formation that could occur throughout the transit of the product.
During the inspection you indicated that your firm will be creating a revised HACCP plan. Your written response did not indicate that your firm will complete a revised plan, and no revised HACCP plan was included for our review. Your written response was partially adequate in that your response states that you will have the herring supplier use transit time and temperature monitoring devices on each shipment; however, we were not provided with records to verify this correction.
3. 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 procedures and frequency of the continuous temperature monitoring of the storage cooler at the Storage Temperature critical control point to control pathogen growth due to temperature abuse listed in your HACCP plan for pickled herring. Continuous temperature monitoring records of the storage cooler were not available for at least three periods of time in which your firm was storing finished, pickled herring in the cooler:
a. On February 8, 2012, your firm produced and stored pickled herring but you did not have a continuous temperature recording chart record for the month of February, 2012.
b. On March 16, 2012, your firm produced and stored pickled herring but you did not have a continuous monitoring recording chart record for the week of March 12, 2012.
c. On April 27, 2012, your firm produced and stored pickled herring but you did not have a continuous monitoring recording chart record for the week of April 23, 2012.
Your written response to this observation is partially adequate in that the response indicated you had a meeting with your employees to discuss the importance of changing the temperature recording charts and that you have designated the responsibility to one individual. However, your response does not identify how your firm will ensure continued compliance and prevent future occurrences.
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.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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: Jessica L. Kocian, Compliance Officer, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have questions regarding any issues in this letter, please contact Jessica Kocian at 425-302-0444.
Charles M. Breen
cc: Washington State Department of Agriculture
PO Box 42560
Olympia, Washington 98504-2560