1Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed wearing non-sterile gloves.
Inspection Record
Palmetto Isotopes LLC — 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
2Environmental monitoring
Inadequate routine environmental monitoring in the ISO 5 area.
3Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
4Aseptic processing and sterility assurance
Smoke studies were not performed under dynamic conditions.
5Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly duty equipment or surfaces.
6Equipment and facility
Use of a sporicidal agent in the facility's classified areas was improper.
About this record
Extracted automatically from the document US FDA published on 2025-03-28. 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.
