1Aseptic processing and sterility assurance
The system for monitoring and maintaining environmental conditions in the aseptic processing areas was deficient.
Inspection Record
Pharmcore Inc. dba Hallandale Pharmacy — FDA 483 Findings
Inspectors Melinda LeeThe 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
Equipment, materials, and/or supplies are not disinfected prior to entering the aseptic processing areas.
3Validation and qualification
IS0-5 classified areas were not certified under dynamic conditions.
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.
