483
Yichang Humanwell Oral Solid Dosage PlantYichang Humanwell Oral Solid Dosage Plant – FDA 483, Nov 16, 2020
Record Details
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.
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ID · 27c0c01e-8b0d-41ff-9a62-c7579555edd8
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