FDA 483 - Yichang Humanwell Oral Solid Dosage Plant - November 16, 2020

The FDA inspected Yichang Humanwell Oral Solid Dosage Plant in Yichang, Hubei, China, and issued a Form 483 with two observations. The inspection revealed deficiencies in batch production and control records, specifically regarding the inclusion of in-process results. Additionally, laboratory controls were found to be inadequate, lacking scientifically sound and appropriate test procedures to ensure drug product quality.