WuXi AppTec Passes FDA Inspections

WuXi AppTec Passes FDA Inspections

WuXi AppTec announced that its API manufacturing sites in Changzhou and Taixing, China, successfully completed back-to-back FDA inspections in March with no observations and no Form 483 issued. This rare achievement highlights the company’s strong commitment to quality and its role in helping global pharmaceutical partners deliver safe, effective therapies to patients worldwide.

The Changzhou facility underwent a GMP surveillance inspection starting March 4, covering 21 FDA-approved products under the agency’s six-system inspection model. The review was completed a day early, with inspectors noting no issues—further reinforcing WuXi AppTec’s leadership in regulatory excellence.

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