1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
Inspection Record
Nebraska Methodist Hospital — FDA 483 Findings
Inspectors Eric M. MuellerThe 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
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.
3Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not appropriate for the duties they perform.
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory detennination of satisfactory conformance to the final specifications prior to release.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Aseptic processing and sterility assurance
A septic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
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.
