1Validation and qualification
The certification of the ISO 5 areas was inadequate.
Inspection Record
Vita Pharmacy, LLC dba Talon Pharmacy of Boerne — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Media fills are not performed that closely simulate aseptic production operations, incorporating, as appropriate, worst case activities and conditions that provide a challenge to aseptic operations.
3Equipment and facility
Your facility design may allow the influx of poor quality air into a higher classified area.
4Cleaning validation
On 10/27/2021, I observed a dark residue on the plastic grille enclosing the HEPA filter located in the ISO 5 workbench area.
5Aseptic processing and sterility assurance
Materials and supplies were not disinfected prior to entering the aseptic processing areas.
6Other quality system
You produced hazardous drugs without providing adequate containment and segregation to prevent cros scontammation.
About this record
Extracted automatically from the document US FDA published on 2022-02-04. 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.
