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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Baugher Enterprise, Inc. 11-Jul-06

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

Public Health Service
Food and Drug Administration

 

Baltimore District Office
6000 Metro Drive
Suite 101
Baltimore, MD 21215-3215
Telephone: (410) 773-5454



FEI: 1113484

July 11, 2006

WARNING LETTER
VLN 06200403

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Allan Baugher, President
Baugher Enterprise, Inc.
1236 Baugher Road
Westminster, MD 21158-3604

Dear Mr. Baugher:

The Food and Drug Administration inspected your firm, located at 1236 Baugher Road, Westminster, MD, on March 14 -April 3, 2006. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 120 & 110). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice 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 apple cider products 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 Juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120 .8(a). However, your firm does not have a HACCP plan for your Unpasteurized Apple Cider to control the food safety hazard of pathogens. Furthermore, your firm does not have a written Hazard Analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify control measures that you can apply to control those hazards, for the Unpasteurized Apple Cider that you process.

2. You must have sanitation control records that document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation control records for the safety of water; the condition and cleanliness of food contact surfaces; the prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, and from raw product to processed product; the maintenance of hand washing, hand sanitizing, and toilet facilities; the protection of food, food packaging materials, and food contact surfaces from adulteration with contaminants; proper labeling, storage, and use of toxic compounds; control of employee health conditions; and, exclusion of pests.

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 juice HACCP regulation (21 CFR Part 120) 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.

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.

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.

Please send your reply to the U.S. Food and Drug Administration, Attention: Randy F. Pack, Compliance Officer at the address above. If you have questions regarding any issue in this letter, please contact Mr. Pack at 410-779-5417.

Sincerely,

/S/

Evelyn Bonnin
District Director