Inspections, Compliance, Enforcement, and Criminal Investigations
Diana Fruit Company Incorporated 7/27/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
July 27, 2011
Gene Acronico, President and CEO
Diana Fruit Company, Inc.
651 Mathew St
Santa Clara, CA 95050
Dear Mr. Acronico:
The Food and Drug Administration (FDA) conducted an inspection of your acidified canned food manufacturing facility, located at 651 Mathew St, Santa Clara, CA 95050, from June 15, 2011 through June 23, 2011. The inspection determined that your facility produced acidified canned food products and revealed that you have significant deviations from the Emergency Permit Control regulations, and Acidified Foods regulations (21 CFR Parts 108, 21 CFR 114).
As a manufacturer of acidified canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified canned food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). 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 canned foods and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35 and 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114 and 21 CFR Part 113. In addition, based upon certain criteria in 21 CFR 114 and 21 CFR 113, acidified and low acid foods may be adulterated within the meaning of section 402(a)(3) of the Act (21 U.S.C. § 342(a)(3)) in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or 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.
During the inspection, our investigators documented deviations from the Act and the above mentioned regulations relating to the processing of Maraschino cherries. The deviations cause your acidified food products to be adulterated and in violation of the Section 402(a)(4) of the Act, in that your Maraschino cherries have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations on the Internet through links on the FDA’s home page at http://www.fda.gov.
The significant violations we found at your acidified food processing facility are as follows:
1. As a commercial processor engaged in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). Specifically, your firm has failed to file a scheduled process for each of the Maraschino cherry products that you manufacture.
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/default.htm.
In addition, your firm failed to register with the FDA as a commercial processor of acidified foods. A commercial processor of acidified foods is required, not later than 10 days after first engaging in the manufacture, processing, and packing of acidified foods, to register and file a Form FDA 2541 with the FDA, as required by 21 CFR 108.25(c)(1).
For additional information on the types of products FDA considers to be acidified foods (including thickened water beverages), please refer to the 2010 Draft Acidified Food Guidance Document at the following link: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/AcidifiedandLow-AcidCannedFoods/ucm222618.htm.
2. Your firm failed to exercise sufficient control, including frequent testing and recording of results, so that the finished equilibrium pH values for acidified foods are not higher than 4.6 as required by 21 CFR 114.80(a)(2). Specifically, your firm does not monitor or record the finished equilibrium pH of the Maraschino cherry products you manufacture to ensure that the finished equilibrium pH does not exceed 4.6.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your written reply to the Food and Drug Administration, Attention: Sergio Chavez, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, please contact Sergio Chavez at (510) 337-6886.
Barbara J. Cassens