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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Three Ann's Seafood 11-Jul-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
Baltimore District Office
Central Region
900 Madison Avenue
Baltimore, MD 21201-2199
Telephone: (410) 962-3396
FAX: (410) 962-2307

July 11,2001
01-BLT-35
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Betty A. Jones, Owner
Three Ann?s Seafood
1123 Keys Road
Fishing Creek, Maryland 21634

Dear Ms. Jones:

The Food and Drug Administration (FDA) conducted an inspection of your crabmeat processing facility located at 1123 Keys Road, Fishing Creek, Maryland, on June 26-27,2001. The inspection revealed deviations from Fish and Fishery Products regulations (Seafood HACCP), Title21, Code of Federal Regulations, Part 123 (21 CFR 123). The deviations cause the seafood you process to be adulterated within the meaning of Section 402(a)(4) of the Food, Drug, and Cosmetic Act (FD&C Act). The deviations are as follows:

1.You must implement the monitoring procedures listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, during the inspection, the FDA investigator observed that you were not implementing the procedures (critical control points) listed in your HACCP plan for crabmeat, including the following:

Your HACCP plan contains a critical limit for picking/packing of crabmeat, which requires a maximum of [redacted] exposure at room temperature beginning when the cooked crabs are first handled in the picking room. Your "Crabmeat Time Records" for production of crabmeat during the current season (2001) does not include the amount of time each batch was exposed to room temperature. For example, the records only contain the time the first batch of crabs were placed on the picking table and the time the last batch was packed.

Your HACCP plan contains a critical limit of [redacted] or the cooking temperature of the live crabs. The production records for the current year (2001) do not contain the thermometer readings for the cooking of the crabs.

Sanitation monitoring records were not maintained for crabmeat production during the current year (2001).

2.You must establish critical limits that are adequate for the intended use, to comply with 21 CFR 123.6(c)(3). Your HACCP plan for crabmeat lists critical limits of [redacted] or no more than [redacted] for storage of fresh crabmeat in the cooler. There was no documentation provided to support a storage temperature of [redacted] rather than the required 40*F.

3. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with21 CFR 123.8(a). However, your firm did not verify the adequacy of the critical limit for time and temperature at the critical control point for retorting (cooking) of live crabs to control pathogen growth. You could not provide documentation that a cook time and temperature of [redacted] will control this hazard.

The above items are not an all-inclusive list of the objectionable conditions observed in your facility. You should take prompt action to correct all deviations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.

Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to the Food and Drug Administration, 900 Madison Avenue, Baltimore, Maryland 21201, to the attention of Rosalie Bucey, Compliance Officer. Ms. Bucey can be contacted telephone number 410/962-3591, extension 143.

Sincerely,

/s/

Acting Director

Baltimore District