Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
February 21, 2014
WARNING LETTER NO. 2014-NOL-11
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Charles Lee McSpadden, Jr., Owner
Apple Valley Orchards
351 Weese Road Southeast
Cleveland, Tennessee 37323
Dear Mr. McSpadden,
The United States Food and Drug Administration (FDA) inspected your pasteurized apple cider processing facility, located at 351 Weese Road Southeast, Cleveland, Tennessee, on October 28 and 30, 2013. The inspection revealed you have serious violations of the Juice Hazard Analysis 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 21 CFR 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food Drug and Cosmetic Act (the Act) [21, USC 342(a)(4)]. These deviations cause your apple cider products to be in violation of 21 CFR 120, promulgated under the authority of Section 361 of the Public Health Service Act (PHS Act). You can find the Act, 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.
The observations of concern were listed on a Form FDA 483, Inspectional Observations (FDA 483), issued to you on October 30, 2013, and include the following:
1. You must have records documenting your HACCP system to comply with 21 CFR 120.12(a)(4)(i). However, your firm did not maintain records documenting the monitoring of critical control points and their critical limits for pasteurized apple cider batch 13029210 manufactured on October 19, 2013.
2. You must maintain sanitation control records that document monitoring and corrections to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation monitoring records for the safety of the water that comes into contact with food or food contact surfaces.
3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practice requirements to comply with 21 CFR 120.6(b). However, your firm did not monitor the protection of food, food packaging material, and food contact surfaces from adulteration as evidenced by:
- The metal apple grinder is not monitored for damage or integrity which could result in a food safety hazard of metal at the apple grinding step;
- Rusted metal exposed on the apple crusher adjacent to where the apples enter the machine;
- Fluorescent glass lights without protective shielding above the pasteurizer, conveyor on the apple crusher, adjacent to the grading/sorting table, and directly over an open wooden bin used to hold apples used for cider production;
- An opening to the outside approximately three inches by five inches directly above the pumice conveyor on the east wall of the apple cider processing room.
4. You must validate your HACCP plan is adequate to control food hazards, which are reasonably likely to occur, at least once within 12 months after implementation and at least annually thereafter to comply with 21 CFR 120.11(b). However, you have not validated your HACCP plan for (b)(4) to determine if it is adequate to control food hazards since May 8, 2012.
5. All persons working in direct contact with food, food-contact surfaces, and food- packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, including wearing, where appropriate, hair nets, headbands, caps, beard covers, or other effective hair restraints, to comply with 21 CFR 110.10(b)(6). However, two female employees in your facility were not wearing hair restraints and one bearded male employee was not wearing a beard cover/net while working on the apple sorting/sizing table.
6. You must provide sufficient space for storage of equipment and materials as is necessary for the maintenance of sanitary operations and assure that aisles or working spaces are provided between equipment and walls to comply with 21 CFR 110.20(b)(1) and (b)(4). However, you stored packaging materials, coolers, crates, and bins against the south wall in the apple receiving and grading room.
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, PHS 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, PHS Act, and all applicable regulations.
Please send your reply to Mark W. Rivero, Compliance Officer, US Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have questions regarding any issue in this letter, Mr. Rivero may be contacted via (504) 832-1290, extension 1103.
Patricia K. Schafer
New Orleans District