1Other quality system
Your finn released drug product in which the strength differs from, or its purity or quality falls below, that which it purpmts or is represented to possess.
Inspection Record
Metro Drugs 3rd Avenue Corp — FDA 483 Findings
Inspectors Rachael A MoliverThe 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
Media fills were not performed that closely simulate aseptic production operations incorporating as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
3Equipment and facility
Inadequate pressure differentials between higher quality air rooms and lower quality air rooms were observed.
4Validation and qualification
ISO-5 classified areas were not certified under dynamic conditions.
5Aseptic processing and sterility assurance
Disinfecting agents and cleaning pads or wipes used in the ISO 5 area aseptic processing areas are not sterile.
About this record
Extracted automatically from the document US FDA published on 2019-07-25. 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.
