1Contamination control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
Inspection Record
Bora Pharmaceuticals Injectables Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
5Equipment and facility
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
About this record
Extracted automatically from the document US FDA published on 2026-07-10. 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.
