Dong-A Otsuka Co. Ltd. – FDA Warning Letter, Aug 20, 2010

On August 19-20, 2010, the FDA inspected Dong-A Otsuka Co., Ltd.'s Chilseo Factory in Korea, identifying serious deviations from acidified food regulations (21 CFR Parts 108 and 114). These failures render their acidified food products, specifically "Pocari Sweat," adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, meaning they were prepared, packed, or held under insanitary conditions.

The inspection resulted in an FDA-483, and the firm's September 29, 2010, response was deemed inadequate. Key violations include: 1. **Failure to file scheduled processes (21 CFR 108.25(c)(2)):** The Chilseo Factory (FCE #15288) lacks filed scheduled processes for acidified non-carbonated beverages manufactured and distributed to the U.S. The firm incorrectly provided a SID from their Anyang Factory, and their response did not include a corrective action for this. 2. **Lack of trained personnel (21 CFR 108.25(f)):** Plant personnel involved in acidification, pH control, heat treatment, or other critical factors are not supervised by an FDA-approved trained person. The firm's ISO 22000 and other certifications do not clearly cover pertinent