Inspections, Compliance, Enforcement, and Criminal Investigations
Carrizozo Orchard 2/20/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
February 20, 2013
Ref: DEN-13-8 WL
VIA UPS Overnight
Mr. James P. Niebaum, Co-Owner and
Mrs. Patricia R. Niebaum, Co-Owner
24 Old Well Road
Datil, New Mexico 87821
Dear Mr. and Mrs. Niebaum:
The Food and Drug Administration inspected your juice processing facility, located at 500 17th Street, Carrizozo, New Mexico, on October 17 and 19, 2012, 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 [21 CFR Parts 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 unpasteurized 100% 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.
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, which listed the deviations found at your firm. Your firm responded to those observations of concern on November 2, 2012. However, your response did not adequately address the FDA-483 observations as further described in this letter.
Your significant violations were as follows:
1. You must have a process that will consistently produce a 5-log reduction of the pertinent microorganism for the shelf life of the product when stored under normal or moderate abuse conditions to comply with 21 CFR 120.24(a), and you must perform final product packaging within a single production facility operating under good manufacturing practices to comply with 21 CFR 120.24(c). However, you repack 100% apple cider into final packaging without a 5-log reduction process being applied directly to the apple cider in your facility.
We have reviewed your response and have determined that it is inadequate to correct the violations. You did not include in your response any documentation of records to verify that you have implemented a 5-log reduction process for your product.
2. You must have and implement a written HACCP plan to control any food safety hazardsthat are reasonablylikely to occur to comply with 21 CFR 120.8(a). However, your firm does not have a HACCP plan for 100% apple cider to control the food safety hazard of pertinent microorganisms.
Your response is inadequate to correct the deviation as you did not provide a written HACCP plan for your 100% apple cider processed in 2012.
3. You must develop, or have developed for you, a written Hazard Analysis to determine whether there are food safety hazards that are reasonable likely to occur in the 100% apple cider juice you process and identify control measures that you can apply to control those hazards as required in 21 CFR 120.7(a).
Your response is inadequate to correct the deviation. You did not provide a written Hazard Analysis for your 100% apple cider processed in 2012.
4. You must have a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing to comply with 21 CFR 120.6(a).
We have reviewed your response and have determined that it is inadequate to correct the violation. You did not include in your response a copy of your SSOP along with any documentation that you have developed to implement the SSOP.
You must have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing to comply with 21 CFR 120.6(a). Furthermore, you must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 120.6(b) to comply with 21 CFR 120.6(c).
Your response did not include a copy of your SSOP, or any documentation that monitors and controls the eight key areas of sanitation:
- The safety of water that comes into contact with food or food contact surfaces or that is used to manufacture ice;
- The condition of cleanliness of food contact surfaces;
- The prevention of cross-contamination from insanitary objects;
- The maintenance of hand washing, hand sanitizing, and toilet facilities;
- The protection of food, food packaging material, and food contact surfaces from adulteration with contaminants;
- The proper labeling, storage, and use of toxic compounds;
- The control of employee health conditions that could result in microbiological contamination of the food packaging materials, and food contact surfaces; and,
- The exclusion of pests from the food plant.
We may take further action if you do not promptly correct these violations. For instance, we may initiate regulatory action without further formal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as copies of your juice HACCP Hazard Analysis, juice HACCP plans, process controls for 5-log reduction of pertinent microorganisms, sanitation monitoring records, related sanitation corrective actions, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the juice HACCP regulation and the Good Manufacturing Practice regulations (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024 or via email at firstname.lastname@example.org.
LaTonya M. Mitchell
Denver District Director