1Deviation, CAPA, and investigation
Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Inspection Record
SSM Health Care St. Louis DBA SSM St. Clare Health Center — FDA 483 Findings
Inspectors Wayne D McgrathThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, identification, testing, approval and rejection of components, drug product containers and closures.
3Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
About this record
Extracted automatically from the document US FDA published on 2022-01-07. 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.
