FDA WARNING_LETTER - Persimmon Hill Farm Gourmet Foods, Inc - May 17, 2012

On May 3-17, 2012, the FDA inspected Persimmon Hill Farm Gourmet Foods in Lampe, Missouri, finding serious deviations from Acidified Food regulations (21 CFR Part 108 and 114) and potential deviations from Juice HACCP regulations (21 CFR Part 120).

For acidified foods, specifically "Shiitake Mushroom Sauce," the firm failed to: - Reprocess or evaluate product (Lot (b)(4)) that deviated from the scheduled process (21 CFR 114.89). A process deviation occurred where the fill temperature and hold time were not met, and the product was not quarantined. - Identify and record process deviations with public health bearing (21 CFR 114.100(c)). This included Lot (b)(4) and Lot (b)(4) of "Shiitake Mushroom Sauce" due to incorrect processing temperatures and a miscalibrated thermometer. - Employ adequate quality control measures (21 CFR 114.80(a)), specifically failing to record calibration activities for pH meters and thermometers for "Shiitake Mushroom Sauce" (Lot (b)(4) and Lot (b)(4)). This was a repeat observation from an August 2010 inspection.

These deviations render the acidified food products adulterated under Section 402(a)(4) of the Act.

For "Elderberry Juice