1Aseptic processing and sterility assurance
There is a lack of assurance of the sterility of prepared sterile human drugs and sterile veterinary drugs includin g injectable and opthalmic drug products.
Inspection Record
MedPark Pharmacy LLC — FDA 483 Findings
Inspectors Stacie Woods · Djamila HarouakaThe 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
The system for maintaining environmental conditions in the aseptic processing areas was deficient.
3Aseptic processing and sterility assurance
The aseptic technique used to prevent microbiological contamination of drug products purporting to be sterile was d eficient.
4Aseptic processing and sterility assurance
The system for cleaning and disinfection of the critical areas used to prepare sterile drug products is deficient.
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.
