1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followw.
Inspection Record
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center — FDA 483 Findings
Inspectors Jessica L Pressley · Jared P Stevens · Seneca D TomsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Written procedures for sampling and testing plans are not followed for each drug product.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easi1y cleanable.
7Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for sterility are not written and followed.
8Laboratory and QC controls
Established test procedures are not documented at the time of performance.
About this record
Extracted automatically from the document US FDA published on 2020-05-04. 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.
