1Aseptic processing and sterility assurance
The segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.
Inspection Record
La Vita Compounding Pharmacy, LLC — FDA 483 Findings
Inspectors Roger F ZabinskiThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
3Aseptic processing and sterility assurance
Equipment was not disinfected prior to entering the aseptic processing areas.
4Contamination control
Your firm produced drugs while construction was underway in an adjacent area without adequate controls to prevent contamination of the production environment and product.
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.
