Inspections, Compliance, Enforcement, and Criminal Investigations
Keyser Brothers Incorporated 10/25/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5705
October 25, 2013
Mr. Robert C. Keyser President
Keyser Brothers Incorporated
965 Honest Point Road
Lottsburg, VA 22511
Dear Mr. Keyser:
From July 29 through August 13, 2013 we inspected your seafood processing facility located at 965 Honest Point Road, Lottsburg, 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 of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operated 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 they may 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.
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 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). However, your firm did not monitor the control of employee health conditions, or the exclusion of pests as evidenced by:
a. An employee was observed wearing a bandage on their left hand while touching ready-to-eat crabmeat. An employee was observed wearing a ring while using their bare hands to pick cooked crabs. Two employees were observed wearing nail polish while using their bare hands to pick cooked crabs. An employee was observed wearing a wrist watch while using their bare hands to pick cooked crabs. An employee undid the Velcro on their shoe with their bare hand and resumed touching ready-to-eat crabmeat without washing or sanitizing their hands.
b. The crab cooking area is completely open to the outside environment, including animals, insects, and pests. There were apparent flies, too numerous to count, flying into the crab cooking area and landing on Mr. Keyser, the open vertical retort, and the metal baskets containing live and cooked crabs. Five apparent flies were observed flying around a red plastic container containing old crab pieces, near the southeastern entrance facing the Coan River. A gap, approximately 4 inches by 5 inches was observed on the bottom of the plastic strip curtains located between the crab picking room and the crab cooking area, which is open to the outside environment.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plans for "Fresh Crabmeat: non-hermetic cups", and "Blue Crab", lists monitoring procedures and frequencies that do not ensure compliance with the critical limit, as evidenced by:
a. Your firm's HACCP plan for ready-to-eat Fresh Crabmeat titled, "Fresh Crabmeat: non-hermetic cups" lists a monitoring procedure and frequency of "(b)(4)" for "(b)(4)" at the "Retort" critical control point. This procedure and frequency is not continuous and does not ensure the control of pathogen survival through cooking.
b. Your firm's HACCP plan for ready-to-eat Fresh Crabmeat titled, "Fresh Crabmeat: non-hermetic cups" lists a monitoring frequency of (b)(4) during (b)(4) at the "Refrigerated Storage" critical control point. This frequency is not continuous and does not ensure the control of pathogen growth.
c. Your firm's HACCP plan for ready-to-eat Fresh Crabmeat titled, "Blue Crab" lists a monitoring frequency of "(b)(4)" at the "Refrigerated Storage" critical control point. This frequency is not continuous and does not ensure the control of pathogen growth.
3. Yon 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 ready-to-eat Fresh Crabmeat titled "Fresh Crabmeat: non-hermetic cups" lists a critical limit of (b)(4) at the "Refrigerated Storage" critical control point. This critical limit does not ensure the control of pathogen growth.
4. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However your firm is not following the recordkeeping procedures at the "Retort" critical control point. Your firm was unable to provide a "Crab Cooking/Recooking Form," as indicated in their HACCP plan for ready-to-eat Fresh Crabmeat titled, "Fresh Crabmeat: non-hermetic cups" for 5/26/12-6/12/12.
5. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8 (a). However your firm is not following the verification procedures at the "Retort" critical control point. Your firm does not perform a monthly calibration on the glass thermometer and pressure gauge on the retort as indicated in your HACCP plan for ready-to-eat Fresh Crabmeat, titled "Fresh Crabmeat: non-hermetic cups."
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 that your processing plant operates in compliance with the Act, and the seafood HACCP regulation(21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Your response to the FDA-483, dated August 30,2013, addressing corrective actions that have been implemented by your firm will be reviewed and assessed during the next inspection.
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. Are-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 there-inspection and assessing and collecting there-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. You should include in your response documentation such as HACCP 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 Food and Drug Administration, Attention: Mrs. Evelyn Bonnin, District Director, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Mr. Ernie Bizjak, Compliance Officer at 410-779-5715 or via email at Emest.Bizjak@fda.hhs.gov.
Virginia Department of Agriculture & Consumer Services
1722 Volvo Parkway
Chesapeake, VA 23320