FDA WARNING_LETTER - Asada Milling Co., Ltd. - October 12, 2012

On March 22, 2013, the FDA issued a Warning Letter to Asada Milling Co., Ltd. following an inspection from October 9-12, 2012, at their API manufacturing facility in Gunma, Japan. The inspection revealed significant Current Good Manufacturing Practice (CGMP) deviations, rendering their APIs adulterated under 21 U.S.C. § 351(a)(2)(B).

Key violations include: 1. **Quality Unit Failures:** The Quality Unit failed to review/release/reject finished APIs, perform annual product quality reviews, and lacked procedures for process validation review, change management, raw material release, and batch record approval. CGMP training and equipment calibration systems were also inadequate. 2. **Equipment and Facility Maintenance:** Manufacturing equipment was corroded, rusted, chipped, and coated with unidentified powder. Visible powder was on equipment, floors, and walls, posing cross-contamination risks. There were no written procedures or schedules for facility sanitation and equipment maintenance. Hundreds of insects were found in processing area insect catchers, indicating inadequate pest control. 3. **Raw Material and Finished API Specifications:** The firm failed to perform identity testing on incoming raw materials, verify COAs, or establish procedures for raw material receipt, identification, quarantine, or storage. No specifications were established for raw materials or finished APIs. 4. **Batch Record Deficiencies:** Batch records were incomplete, lacked