FDA WARNING_LETTER - Delori Industrial Co., Ltd. - October 30, 2019

The FDA inspected Delori Industrial Co., Ltd. in China from October 28-30, 2019, finding serious deviations from Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. The firm's responses on November 20, 2019, February 19, 2020, and March 6, 2020, were deemed inadequate.

Key violations include: 1. Failure to process acidified food (dairy beverages) in conformity with the scheduled process, specifically regarding finished equilibrium pH and thermal processing time/temperature. 2. Operators not being supervised by a person who has completed an FDA-approved course in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification. This was evidenced by the firm's inability to identify scheduled processes and by thermal process monitoring records showing incorrect, missing, or non-compliant process times.

These violations render the firm's acidified dairy beverage products adulterated under section 402(a)(4) of the Act. The FDA may refuse admission of products under section 801 of the Act, including detention without physical examination (DWPE) via Import Alert #99-38.

The firm must respond in writing within 15 working days, outlining specific corrective actions,