1Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Inspection Record
Buderer Drug Company, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated and were observed with exposed skin during aseptic processing.
3Aseptic processing and sterility assurance
Pressure differentials between areas with different air classifications were not monitored prior to or during sterile drug production.
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.
