1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Region Care Inc. (Northwell Health) — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
4Laboratory and QC controls
Laboratory controls do not include a determination of conformance to appropriate specifications for drug products.
5Aseptic processing and sterility assurance
Drugs products purporting to be sterile and pyrogen-free are not laboratory tested to determine conformance with such requirements.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
7Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
8Aseptic processing and sterility assurance
Clothing of personnel engaged in compounding of sterile 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.
