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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Glen Willow Orchards 22-Jan-08

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

Public Health Service
Food and Drug Administration

 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390


WARNING LETTER

08-PHI-06

January 22, 2008

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Steven R. Rosazza &
Thomas C. Rosazza, Co-Owners
Glen Willow Orchards
1657 Glen Willow Road
Avondale, Pennsylvania 193111-9528

Dear Messrs. Rosazza:

We inspected your juice processing facility, located at 1657 Glen Willow Road, Avondale, Pennsylvania, on October 22-24, 2007. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 120 which was promulgated under the authority of Section 361 of the Public Health Service Act (PHS Act), 42 U.S.C. § 264. You can find the PHS 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 violation is as follows: You must have and implement 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 apple cider to control the food safety hazard of pathogens. All juice processors (except retail establishments as defined in the regulation) must comply with the juice processing regulation for each type of juice they produce. A processor that sells or distributes juice to other business entities is not a retail establishment (21 CFR 120.3(1)). Because your firm sells juice wholesale, it does not qualify as a retail establishment and is subject to the juice processing regulation.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to 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.

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 PHS Act and the juice HACCP regulation (21 CFR Part 120). You also have a responsibility to use procedures to prevent further violations of the PHS Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: William J. Forman, Compliance Officer, at the above letterhead address. If you have questions regarding any issue pertinent to the inspection, please contact Joseph L. Despins, Investigator, at 302-573-6447 x 107.

Sincerely,

/S/

Thomas D. Gardine
District Director, Philadelphia District
U.S. Food and Drug Administration

cc:
Pennsylvania State Department of Agriculture
Bureau of Foods & Chemistry
2301 North Cameron Street
Harrisburg, PA 17120-9408