1Equipment and facility
The facility design was observed to allow the influx of lesser quality air into a classified area containing higher quality air.
Inspection Record
Strive Pharmacy Texas LLC — FDA 483 Findings
Inspectors Camerson E MooreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Cleaning of equipment and glassware is inadequate.
3Equipment and facility
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
4Aseptic processing and sterility assurance
Personnel performed aseptic manipulations with exposed hair or skin.
About this record
Extracted automatically from the document US FDA published on 2023-10-12. 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.
