1Contamination control
The separate or defined areas necessary 10 prevent contamination or mix-ups are deficie nt .
Inspection Record
Unique Pharmaceutical, Ltd — FDA 483 Findings
Inspectors Stephen D. BrownThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
5Other quality system
Specifically, your firm failed to conduct surface monitoring REDACTED (b)(4) (i.e.
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.
