1Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Inspection Record
SSM Health Care St. Louis DBA SSM St. Clare Health Center — FDA 483 Findings
Inspectors Tiara N Brown-CrosenThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining equipment used to control the aseptic conditions.
3Labeling and packaging
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written.
4Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding tbe system for monitoring envirorunental conditions.
6Stability and storage
Results of stability testing are not used in determining expiration dates.
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.
