1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Inspection Record
Fresenius Kabi USA LLC — FDA 483 Findings
Inspectors Brian D Nicholson · Michele L GlendenningThe 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
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
4Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
About this record
Extracted automatically from the document US FDA published on 2021-01-29. 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.
