Inspections, Compliance, Enforcement, and Criminal Investigations
Kime's Cider Mill 04-Apr-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
April 4, 2005
Mr. Randy Kime, Co-owner
Kime's Cider Mill
171 Church Street
Bendersville, PA 17306
Dear Mr. Kime:
We inspected your firm, located at 171 Church Street, Bendersville, Pennsylvania, on October 18, 19, and 20, 2004, and also visited your firm on November 10, 2004, to obtain additional information . We found that your "Kime's Pasteurized Apple Cider ALL NATURAL . . . NET 1 pt. (473ml) . . . BEST USED BY 11/16/04" (apple cider) is adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C . § 342(a)(1), due to the presence of patulin . We also found that you have a serious deviation from the Juice Hazard Analysis Critical Control Point (HACCP) regulation (21 CFR Part 120), which causes your apple cider to be in violation of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 342(a)(4). The deviations are explained more fully below.
On October 19, 2004, an investigator from our office collected a sample of your apple cider. On November 5, 2004, a Compliance Officer from our office notified you via telephone that our analysis of this product showed it contained 116.9 ppb patulin, with a check analysis of 107.4 ppb patulin. Also, on November 10, 2004, our investigator visited your firm to obtain distribution records related to this product. Patulin is a toxic substance produced by molds that may grow on apples.
The article of food (apple cider) is adulterated when introduced into interstate commerce within the meaning of section 402(a)(1) of the Act, 21 U.S.C. § 342(a)(1), in that it bears or contains an added poisonous or deleterious substance, patulin, which may render the article of food injurious to health. In addition, we found that you have a serious deviation from the Juice HACCP regulation found in Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). Failure of a processor to have and to implement a HACCP system that complies with 21 CFR 120.6, 120.7 and 120.8, or to otherwise operate in accordance with the requirements of this part, shall render the juice products of that processor adulterated under section 402(a)(4) of the Act. You can find this Act and the juice HACCP regulations through links in FDA's home page at www.fda.gov. The serious deviation we found is as follows:
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 did not maintain sanitation control records for the following: safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice; condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and exclusion of pests from the food plant.
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.
It is essential that you respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things that you are doing to correct these deviations. You may wish to include in your response documentation such as copies of your HACCP plan for your 100% pasteurized shelf stable apple juice, copies of Sanitation Standard Operating Procedure (SSOP) records, 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 HACCP regulation, and the Current Good Manufacturing Practice regulation for foods, 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 . Please send your reply to the Food and Drug Administration, Attention: Rhonda J . Walley, Compliance Officer, at the address noted in the letterhead. If you have questions regarding any issue in this letter, please contact Ms . Walley at 215-597-4390, extension 4406.
Peter Baker for Thomas D. Gardine