- Vella Cheese Company of California Inc.
- Issuing Office:
- San Francisco District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700
United Parcel Service
Delivery Signature Requested
November 6, 2014
Mr. Gabriel T. Luddy, Plant Manager
Vella Cheese Company of California Inc.
315 2nd Street East
Sonoma, CA 95476
Dear Mr. Luddy:
During the period of July 16th through July 29th, 2014, the U.S. Food and Drug Administration (FDA) conducted an inspection of your cheese processing facility located at 315 2nd St. E, Sonoma, California. Our inspection revealed violations of Section 404 of the Federal Food, Drug, and Cosmetic Act (the Act) and implementing regulations related to processing low-acid food products packaged in hermetically sealed containers. Based on your firm’s practice of shipping hermetically-sealed cheese in unrefrigerated conditions combined with FDA sample results indicating product pH about 4.6 and water activity above 0.85, your “Bear Flag Brand High Moisture Monterey Jack Cheese” and “Bear Flag Brand Mezzo Secco Monterey Jack Cheese” are low-acid food products, as defined by 21 CFR 113.3(n).
As a manufacturer of low-acid food products packaged in hermetically sealed containers, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary Emergency Permit may be required for low-acid foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR 113.
In addition, based upon certain criteria in 21 CFR 113, low-acid foods may be adulterated within the meaning of Section 402(a)(4), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the low-acid food regulations through links on FDA’s Internet home page at http://www.fda.gov.
During the inspection, the FDA investigator documented violations of the Act and the above mentioned regulations relating to the processing of low-acid hermetically sealed cheese products. The significant deviations are as follows:
1. Your firm failed to register with the FDA as a commercial processor of low-acid foods. A commercial processor of low-acid foods is required, not later than 10 days after first engaging in the manufacture, processing, and packaging of thermally processed low-acid foods in hermetically sealed containers in any state, as defined in section 201(a)(1) of the Act, to register and file a Form FDA 2541 (food canning establishment registration) with the FDA, as required by 21 CFR 108.35(c)(1). However, our inspection indicates that your firm processes low-acid foods without registering with the FDA. These include Bear Brand High Moisture Monterey Jack Cheese and Bear Brand Mezzo Secco Monterey Jack Cheese.
2. As a commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers, you must, not later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled processes including, but not limited to, the processing method, type of retort or other thermal processing equipment employed, minimal initial temperatures, times and temperatures of processing, sterilization value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process for each low-acid food in each container size, to comply with 21 CFR 108.35(c)(2). Your firm manufactures low-acid foods packaged in hermetically sealed containers which include your Bear Brand High Moisture Monterey Jack Cheese and Bear Brand Mezzo Secco Monterey Jack Cheese products. However, you have not filed processing information with FDA for these products in accordance with the requirements of 21 CFR 108.35(c)(2).
Scheduled processes must be established by qualified persons having expert knowledge acquired through appropriate training and experience in the thermal processing of low-acid foods in hermetically sealed containers, as required by 21 CFR 113.83.
The issues discussed in this letter and on the Form FDA 483 are not intended to be an all-inclusive statement of the objectionable conditions that exist at your facility. You are responsible for assuring your processing facility is operating in compliance with the Act, the Emergency Permit Control regulation (21 CFR 108), and the Low-Acid Canned Food regulation (21 CFR 113). It is also your responsibility to assure not only the current objectionable conditions are corrected, but appropriate policies and procedures are implemented to prevent recurrence of the problems. You should take prompt action to correct these violations. Failure to make corrections could result in regulatory action without further notice. Possible actions include, but are not limited to, seizure, injunction, and/or the issuance of an order requiring a permit before delivery of introduction or introducing your low-acid products into interstate commerce.
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)). 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 notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps you have taken to correct the violations described above. Include in your response documentation to show correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference our CMS number 439555.
If you have any questions with regard to this letter, please contact Brandon Bridgman, Compliance Officer, at 510-337-6794 or Brandon.Bridgman@fda.hhs.gov
Kathleen M. Lewis, J.D.
San Francisco District Office