1Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
Inspection Record
Carolina Infusion — FDA 483 Findings
Inspectors Taichun QinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Hazardous drugs and Highly potent drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
3Material and supplier control
Materials were exposed to lower than ISO 5 quality air.
4Environmental monitoring
Inadequate routine environmental monitoring in the ISO 5 area.
5Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
6Other quality system
Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air.
About this record
Extracted automatically from the document US FDA published on 2025-02-28. 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.
