1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products purpo1i ing to be sterile are not established, written, or followed.
Inspection Record
Biocon Sdn. Bhd. — FDA 483 Findings
Inspectors Eileen A. Liu · Patty P. KaewussdangkulThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Employees engaged in the manufacturing and processing of a diug product lack the training required to perfo1m their assigned functions.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
4Material and supplier control
There is a failure to thoroughly review 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.
5Other quality system
Conective and preventative action activities and/or results have not been adequately documented.
6Laboratory and QC controls
Your fnm fails to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods.
About this record
Extracted automatically from the document US FDA published on 2023-08-14. 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.
