FDA WARNING_LETTER - Diana Fruit Company Incorporated - June 23, 2011

An FDA inspection of Diana Fruit Company Incorporated's acidified canned food manufacturing facility at 651 Mathew St, Santa Clara, CA 95050, from June 15-23, 2011, revealed significant deviations from Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. The facility produces acidified canned food products, specifically Maraschino cherries, which were found to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to preparation, packing, or holding under insanitary conditions.

Key violations include: 1. Failure to file a scheduled process for each Maraschino cherry product, as required by 21 CFR 108.25(c)(2). This information must be submitted on Form FDA 2541a. 2. Failure to register with the FDA as a commercial processor of acidified foods, as required by 21 CFR 108.25(c)(1). This registration must be filed on Form FDA 2541 within 10 days of engaging in manufacturing. 3. Failure to exercise sufficient control, including frequent testing and recording of results, to ensure finished equilibrium pH values for acidified foods are not higher than 4.6, as required by 21 CFR 11