1Deviation, CAPA, and investigation
Written records of investigation into unexplained discrepancies and the fai lure of a batch or any of its components to meet specification do not always include the conclusions and follow-up.
Inspection Record
Sichuan Deebio Pharmaceutical Co. Ltd. — FDA 483 Findings
Inspectors Arsen Karapetyan · Anders W. EvensonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Written procedures are not established nor followed for the cleaning and maintenance ofequipment, including utensils used in the manufacturing, processing, packing, or holding ofa drug product.
3Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug substance have the identity, strength, purity, and quality that they are purported or represented to possess.
4Laboratory and QC controls
Laboratory records are not completed contemporaneously and do not include complete data derived from all tests to assure compliance with established specifications and standards.
5Other quality system
Control procedures are not established which validate the performance of distribution processes that may be responsible for causiruLvariabjlity in the characteristics ofthe drug substance.
About this record
Extracted automatically from the document US FDA published on 2024-02-08. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
