Russell Hall Seafood, Inc. 7/31/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
July 31, 2013
Return Receipt Requested
Mr. Harry C. Phillips, Owner and President
Russell Hall Seafood, Inc.
2501 Old House Point Road
Fishing Creek, MD 21634
Dear Mr. Phillips:
We inspected your firm, a seafood processor, located at 2501 Old House Point Road, Fishing Creek, MD 21634, on July 1, 2, and 10, 2013.
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 fish and fishery products are adulterated, as they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the current edition of the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
Specifically, our inspection of your facility revealed the following seafood HACCP violations:
1.) You must have an individual associated with your firm who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the FDA, or is otherwise qualified through job experience, as required by 21 CFR 123.10. As of July 10, 2013, no one associated with your firm was found to have been adequately trained.
2.) You must conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product you process to determine whether there are food safety hazards which are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards which are reasonably likely to occur, to comply with 21 CFR 123.6(b) and (c). Specifically, your firm does not have the following:
- A written HACCP plan for bluefish to control the hazard of histamine formation that is reasonably likely to occur at receiving and storage.
- Your HACCP plan for “Fresh Crabmeat; non-hermetic cups” specifies a critical limit at the Fresh Crabmeat Cooler critical control point of “Cooler Temp. 40 degrees or warmer for greater than 6 hours Or Presence/Absence of Ice”. You do not document visual observations of the presence or absence of ice when observing temperatures of the raw and cooked Fresh Crabmeat Coolers.
- Monitoring procedures for your HACCP plan “Fresh Crabmeat; non-hermetic cups” do not specify the use of continuous recording equipment to monitor the cook step. The retort used to cook crabs for picking fresh crabmeat does not include continuous monitoring or recording equipment.
3.) 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). Specifically, the following conditions were observed:
- On 7/1/13, 7/2/13, and 7/10/13, employees were observed using a portable toilet located outside the firm that was not equipped with hand-washing or hand-sanitizing facilities.
- On 7/1/13, there was no detectable chlorine in the shovel dip for the shovel used to shovel cooked crabs into the tubs used to distribute cooked crabs to the crab meat pickers.
- On 7/1/13, two apparent earwigs and approximately six apparent flying insects were observed in the crab picking room during picking.
4.) You must maintain sanitation control records during processing with sufficient documentation to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(c). Specifically, you were unable to provide records or other evidence that sanitation monitoring was conducted outside of blue crab season, between 11/25/12 and 4/7/13, when the firm continued to receive, pack and store finfish; freeze and store fresh crabmeat; and receive and store raw oysters; except for twice daily temperature monitoring of the cooked and raw coolers.
5.) You must maintain records that relate to the general adequacy of your processes for at least two years after their applicability to the product you produced ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.9(b)(2). Specifically, you were unable to provide written documentation or other evidence that a scientific study establishing the thermal process (process validation) was completed.
6.) You must maintain records of calibration of process-monitoring instruments to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.8(d). Specifically, you were not able to provide records of calibration of the thermometers located in the retort, the raw cooler, or the cooked cooler.
7.) You must review critical control point records within one week after the records were made to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.8(a)(3). Specifically, critical control point records were not always reviewed within one week, including, but not limited to the “Crab Process Schedule Cook Form” (dated 6/25/13 to 6/28/13), and the “Cooler Temperature Log” (dated 10/13-10/23, 4/22-4/30, and 6/21-6/29). The “Crab Process Schedule Cook Form”, dated 5/11/13-5/15/13 does not include the reviewer’s signature or date.
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.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and the seafood HACCP regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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-1(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, as well as the remaining issues cited on the FDA-483, Inspectional Observations, issued to you on July 10, 2013. You should include in your response documentation such as a HACCP plan 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.
Please send your reply to the U.S. Food and Drug Administration, Attention: Evelyn Bonnin, Baltimore District Director, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Randy Pack at 410-779-5417 or firstname.lastname@example.org
Baltimore District Office
Robin Henderson, Chief
Center for Food Processing
6 St. Paul Street
Baltimore, Maryland 21202