1Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed upper face.
Inspection Record
Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy) — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Personnel manually contacted the inner surface of the container closure during aseptic production.
3Aseptic processing and sterility assurance
Media fill studies are not conducted to closely simulate aseptic production operations.
4Aseptic processing and sterility assurance
You had inadequate HEPA filter coverage and airflow over tbe area which sterile product was exposed.
5Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 Classified aseptic processing areas were not sterHe.
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.
