1Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
Inspection Record
La Vita Compounding Pharmacy, LLC — FDA 483 Findings
Inspectors Zachary A Bogorad · Nathaniel B Phillips SylvainThe 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 ISO 5 classified aseptic processing areas had particle generating and visibly dirty equipment or surface.
3Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in an area adjacent to the ISO 5 classified aseptic processing area during aseptic production.
4Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
About this record
Extracted automatically from the document US FDA published on 2020-05-04. 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.
