Wuxi Biologics Co Ltd – FDA EIR, Apr 2, 2021

An FDA surveillance inspection of Wuxi Biologics Co Ltd, a contract manufacturer of biological therapeutic drug substances and products in Wuxi, China, was conducted from March 22 to April 2, 2021. The inspection, performed under current Good Manufacturing Practices (cGMP) regulations, assessed key systems including Quality, Production, Materials, Facilities and Equipment, and Laboratory operations, in addition to pre-approval inspection objectives such as data integrity.

At the inspection's conclusion, a six-item FDA Form 483 was issued. Significant observations included insufficient controls over computer systems to prevent data changes, deficiencies in the Quality Unit's oversight of controlled document issuance, and inadequate schedules for equipment preventative maintenance. Other issues involved incomplete specifications for components lacking sampling plan descriptions, inconsistent effectiveness checks for corrective actions stemming from deviation investigations, and a failure to thoroughly investigate unexplained discrepancies or batch failures to meet specifications.

Company management acknowledged the observations and committed to implementing necessary corrections, indicating they would submit a written response to the FDA 483. The inspection was classified as "Voluntary Action Indicated" (VAI), signifying that the firm is expected to address the identified issues.