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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Millington Seafood LLC 10/3/12


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive
Baltimore, MD  21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705


Warning Letter
CMS# 358178
October 3, 2012
Mr. David Bishel, General Manager
Millington Seafood, LLC
407 Back Street
Millington, MD 21651
FEI: 3005154398
Dear Mr. Bishel:
We inspected your seafood processing facility, located at 407 Back St, Millington, MD 21651, on August 22, 27 and 29, 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, (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 histamine and non-histamine 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 do not have a written HACCP plan for your histamine and non histamine forming (b)(4).          21CFR 123.6 (b)
  2. Your HACCP plan for (b)(4) does not list the food safety hazards associated with the product.          21 CFR 123.6 (c)(1)
  3. Your HACCP plan for (b)(4) lists a critical limit that does not ensure control of one or more hazards.          21 CFR 123.6(c)(3)
  4. You are not reviewing critical control point monitoring records of your (b)(4) within one week.          21 CFR 123.8(a)(3)
  5. You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance to CGMPs.          21 CFR 123.44(b)
  6. You are not maintaining sanitation control records that document monitoring and corrections of sanitation deficiencies for safety of water.          21 CFR 123.11 (c)
Our investigator discussed additional inspectional observations during your close out meeting. These verbal items in addition to the FDA-483 items are expected to be addressed.
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. In your response you should include 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). 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: Ms. Evelyn Bonnin, District Director. If you have questions regarding any issues in this letter, please contact Compliance Officer, CDR Rochelle B. Young, RPh, MSA at 410-779-5437.
Evelyn Bonnin
Baltimore District Director