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April 3, 2006
Warning Letter
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Lynn Miller
President
Royal Crest Dairy, Inc.
350 South Pearl St.
Denver, CO 80209
Ref. Den-06-12
Dear Mr. Miller:
An investigator from the U.S. Food and Drug Administration (FDA) inspected your juice processing facility, located at 800 Weaver Park Road, Longmont, Colorado on December 16 - 23, 2005. 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 (21 CFR 120), and the Current Good Manufacturing Practice regulation for food, 21 CFR 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 pasteurized Royal Crest Dairy 100% Pure Orange Juice From Concentrate is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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:
You must have a HACCP plan that lists monitoring procedures for each critical control point, to comply with 21 CFR 120.8(b)(4). However, your firm's HACCP plan for pasteurized orange juice lists a monitoring procedure at the [redacted] critical control point that is not adequate to control the food hazard of pathogens . Specifically, your monitoring procedure does not include a procedure for measuring the time parameter of your critical limit.
You must fully document, in records, all corrective actions taken, to comply with 21 CFR 120.10(c). However, you did not document that a corrective action was taken when, on [redacted], you deviated from your critical limit of [redacted] seconds for orange juice at the [redacted] critical control point to control pathogens. Specifically, the HTST Temperature and Flow Chart for [redacted] does not include a divert valve status graph line to indicate a functioning divert valve or any other recording concerning the corrective action taken when a deviation from the temperature parameter of your critical limit occurred.
You must have records documenting your Hazard Analysis Critical Control Point (HACCP) system, to comply with 21 CFR 120.12(a). However, your firm maintained records documenting the ongoing application of the HACCP plan, including monitoring of critical control points and their critical limits that are not adequate to comply with 21 CFR 120.12(a)(4). Specifically, your HTST Temperature and Flow Charts dated [redacted] include gaps in the temperature indicating graph lines. These charts do not contain adequate information to determine if the orange juice produced during these pasteurization cycles was produced in accordance with your firm's critical limits.
You must have sanitation control records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation control records for 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; and controls of employee health conditions that could result in contamination of food, food packaging materials, and food contact surfaces. This deviation was previously brought to your attention in our letter dated April 27, 2005.
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.
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.
Please send your reply to the Food and Drug Administration, Attention: William H. Sherer, Compliance Officer, P.O. Box 25087, Denver, CO 80225-0087.
Sincerely,
/S/
B. Belinda Collins
District Director
Department
of Health and Human Services