Inspections, Compliance, Enforcement, and Criminal Investigations
Hidden Valley Mills 17-Aug-07
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
August 17, 2007
Frank Stolarczyk, President
Hidden Valley Mills,
dba Bernard Jensen Products
535 Stevens Avenue West
Solana Beach, CA 92075-2043
Dear Mr. Stolarczyk:
We inspected your juice processing facility, located at 535 Stevens Avenue West, Solana Beach, California on April 12, 2007, and found that you have serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). 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 black cherry, Concord grape, apple, and pomegranate concentrates 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 HACCP regulation and the juice HACCP guidance documents through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1) 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) and 21 CFR 120.12(a)(3). However, your firm does not have a HACCP plan for your black cherry, Concord grape, apple, and pomegranate concentrates to control the food safety hazards of Pathogen survival during processing and pathogen growth subsequent to processing.
2) You must have sanitation control records that document monitoring and corrections, to comply with 21 CFR 120.6(c) and 21 CFR 120.12(a)(1). However, your firm is not maintaining any sanitation control records for the eight key sanitation conditions and practices required by21 CFR120.6(a).
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act, 21 U.S.C. § 331(dd). Our records indicate that, to date, your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration maybe accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in automatic confirmation of an registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1 800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food & Drug Administration, HFS-681
5800 Fishers Lane
Rockville, MD 20857
When completed, the form maybe faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the juice HACCP regulation. We may also take further action to enjoin your firm from operating in violation of Section 415 of the Act(21 U.S.C. § 350d) and 21 CFR Part 1, Subpart H.
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 Act, the juice HACCP regulation (21 CFR Part 120) and the Current Good Manufacturing Practice regulation (21 CFR Part 110), and is registered in accordance with the Food Facility Registration regulation (21 CFR Part 1, Subpart H). 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 U.S. Food and Drug Administration, Los Angeles District Office, 19701 Fairchild, Irvine, CA 92612-2445, Attention: Ms. Pamela B. Schweikert, Director, Compliance Branch. If you have any questions regarding any issue in this letter, please contact Mr. Robert McNab, Compliance Officer at (949) 608-4409.
Alonza E. Cruse
Los Angeles District
cc: Department of Health Services
Attn: Chief, Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA 95899-7413