Inspection Record

SSM Health Care St. Louis DBA SSM St. Clare Health Center — FDA 483 Findings

US FDAInspected 2019-08-28Published 2020-02-24 8 findingsQuality unit oversightEquipment and facilityAseptic processing and sterility assuranceLaboratory and QC controlsTraining and personnel

Inspectors Mindy M ChouThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Quality unit oversight

Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release.

2Equipment and facility

Adequate ventilation is not provided.

3Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

4Laboratory and QC controls

Written specifications for laboratory controls do not include a description of the sampling and testing procedures used.

5Laboratory and QC controls

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.

6Training and personnel

Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations.

7Training and personnel

Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.

8Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

About this record

Extracted automatically from the document US FDA published on 2020-02-24. 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.

Other records for this company

2018-10-24 · US FDA · 6 findings2021-09-28 · US FDA · 4 findings
SSM Health Care St. Louis DBA SSM St. Clare Health Center company profile — full history US FDA documents, 2020 Go to Findings search