1Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
Inspection Record
Exela Pharma Sciences LLC — FDA 483 Findings
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 whether or not the batch has been already distributed.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
4Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
7Aseptic processing and sterility assurance
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
About this record
Extracted automatically from the document US FDA published on 2019-10-18. 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.
