1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Inspection Record
Ambient Healthcare of Central Florida Inc — FDA 483 Findings
Inspectors Michael H TollonThe 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
Test procedures relative to appropriate laboratory testing for sterility are not followed.
3Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
4Aseptic processing and sterility assurance
Aseptic processing areas are defic ient regarding the system for monitoring environmental conditions.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
7Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
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.
