1Aseptic processing and sterility assurance
Non-depyrogenated equipment was used in sterile drug production.
Inspection Record
Mandell's Clinical Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
You produced highly potent drugs without providing adequate cleaning of work surface and cleaning of utensils to prevent cross-contamination.
3Aseptic 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.
4Other quality system
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.
About this record
Extracted automatically from the document US FDA published on 2020-01-31. 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.
