1Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean equipment or surface.
Inspection Record
Thrifty White Drug #762 — FDA 483 Findings
Inspectors Anthony J Ladner · Ross J GrigsbyThe 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
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
3Aseptic processing and sterility assurance
Equipment was and Materials or supplies were not disinfected prior to entering the aseptic processing areas.
4Aseptic processing and sterility assurance
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.
5Validation and qualification
ISO 5 classified areas were not certified under dynamic conditions.
6Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
