1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Fresenius Kabi Compounding LLC — FDA 483 Findings
Inspectors Jonathan G Matrisciano · Lori M Newman · Daniel L ZhengThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, 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.
3Equipment and facility
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
6Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
7Material and supplier control
Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
About this record
Extracted automatically from the document US FDA published on 2026-01-20. 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.
