Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
VIA United Parcel Service
December 2, 2015
Alexander F. Lehman, CEO
Lehman Family Farms, Inc dba Home Grown Cellars
13702 Road 20
Madera, CA 93637-9222
Dear Mr. Lehman:
The U. S. Food and Drug Administration (FDA) inspected your fruit juice manufacturing facility, located at 13702 Road 20, Madera, CA, from August 21, 2015 through September 21, 2015. This inspection revealed serious violations of 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 to have and implement a HACCP plan that complies with the requirements of 21 CFR 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 juices 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 on the FDA’S homepage at www.fda.gov.
During our inspection, it was noted that your firm sells products directly to retail customers, in addition to producing juices for wholesale customers at the same location. Retail establishments that make and sell juice directly to customers and do not sell or distribute to other businesses are exempt from the Juice HACCP regulation. For the purposes of CFR Part 120, an establishment that sells or distributes juice to other businesses as well as directly to consumers is not considered a retail establishment. Because your firm sells or distributes juice products to both wholesale accounts and directly to retail customers from your location in Madera, CA, your firm is not exempt from the juice HACCP regulation.
In addition, you cannot use the warning statement described in 21 CFR 101.17(g)(2)(ii) as an alternative to compliance with the juice HACCP regulation because the warning label statement is not applicable to your products. Furthermore, because your firm does not qualify for the retail exemption under 21 CFR 120.3(l), all of your juice products produced by your firm, including 100% pomegranate juice, apple juice, and 100% pomegranate frozen juice bar, are subject to the juice HACCP regulation.
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. These violations include, but are not limited to, the following:
1. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction of pertinent microorganisms, for a period as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a). However, your HACCP plan for your “Pomegranate Juice/Ice Wink Juice Bars” provided to our investigator on August 31, 2015 contains two (2) critical control points (CCPs); (b)(4) and another at the (b)(4) step. The critical limits at the (b)(4) CCP of (b)(4) and the critical limit at the (b)(4) CCP of (b)(4) have not been validated to achieve a 5-log reduction of the pertinent microorganisms for each of your 100% juice products, as required by 21 CFR 120.24(a).
2. You must have a HACCP plan that lists all of the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). However, your firm’s revised HACCP plan for your “Pomegranate Juice/Ice Wink Juice Bars” provided to our investigator on August 31, 2015, does not list the microbiological food safety hazards of vegetative bacterial pathogens.
3. You must maintain sanitation standard operating procedure records, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation monitoring records for the following areas:
- 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;
- Proper labeling, storage, and use of toxic compounds;
- 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 initiate a 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 fifteen (15) business days from your receipt of this letter. Your response should outline the specific actions you have taken to correct these violations. Include in your response documentation of the corrections your firm has taken, or other useful information that may assist us in evaluating your corrections. If you cannot complete all corrective actions within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), and other applicable regulations. 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)]. 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 written reply to the Food and Drug Administration, Attention:
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference CMS number 480589 in your response.
If you have any questions regarding this letter, please contact Sergio Chavez at (510) 337-6886.
Kathleen M. Lewis, J.D.
Director, San Francisco District