1Other quality system
Inadequate Trending analysis to identify potential issues that could impact product quality.
Inspection Record
Biocon Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
Cleaning procedures are inadequate, specifically: During the observation of manual glassware cleaning in Grade D washroom F072 all product contact surfaces were not exposed to the cleaning agent © .
3Equipment and facility
Inadequate equipment qualification/verification based on the documents provided.
4Laboratory and QC controls
Operating procedure for dispensing ofaa for manufacturing purposes does not reflect Quality Control sampling procedure for the routine monitoring of the system.
5Environmental monitoring
Environmental monitoring is deficient.
6Material and supplier control
Inadequate behaviors to prevent contamination of raw materials were observed during the dispensing of raw materials for formulation ) specifically: A.
7Other quality system
Disinfection efficacy is incomplete or not adequately demonstrated, specifically: (b) (4) .
About this record
Extracted automatically from the document US FDA published on 2018-05-17. 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.
