1Other quality system
RecDrds assDciated with'drug product productiDn and cDntrDI and within the retentiDn periDd fDr such records, were not made readily available for authorized inspectiDn.
Inspection Record
Amylin Pharmaceuticals Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The persons double-checking the <:leaning and maintenance are not datitig and sigoing or initialing the equipment cleaning and,use Jog.
3Deviation, CAPA, and investigation
Written records ofinvestigations into unexplained discrepancies and the failure of a batch or any ofits components to meet, specifications do not always include the conclusions and follow-up.
4Laboratory and QC controls
Established laboratory control mechanisms are not documented at the time of performance.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdmg products purporting to be sterile are not established and followed.
6Process validation
Written production and process control procedures are not followed in the execution ofproduction and proe,:ss_control functions.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
