1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established or followed.
Inspection Record
Biocon Sdn Bhd — 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 test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
3Equipment and facility
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.
4Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product or other drug products that may be associated with the specific failure or discrepancy.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
6Process validation
Written production and process control procedures are not followed in the execution ofproduction and process control functions.
About this record
Extracted automatically from the document US FDA published on 2018-03-12. 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.
