1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Sina LLC, dba OncoMed (Onco 360) — FDA 483 Findings
Inspectors Robert C. SteyerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
3Equipment and facility
Records are not always kept for the cleaning of equipment.
4Aseptic processing and sterility assurance
Drug products purporting to be sterile and pyrogen-free are not laboratory tested to dete rmine conformance to such requirements.
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.
6Equipment and facility
There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for cleaning and maintenance operations.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
8Laboratory and QC controls
Laboratory controls do not include a determination of conformance to appropriate specifications for drug 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.
