1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
Inspection Record
KRS Global Biotechnology, Inc — FDA 483 Findings
Inspectors Joanne E. KingThe 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
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
3Laboratory and QC controls
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
4Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
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.
