1Aseptic processing and sterility assurance
Procedures designed to prevent mict•obiological contamination ofdrug products purporting to be sterile are not established and written.
Inspection Record
Hunter Holmes McGuire Veterans Affairs Medical Center — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Written records are not made ofinvestisations h1to unexplained discrepancies.
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.
About this record
Extracted automatically from the document US FDA published on 2025-06-20. 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.
