1Other quality system
There are discrepancies between the information submitted in andthe : manufacturing process performed at Biocon Ltd.
Inspection Record
Biocon Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The OOS procedure [BF/QA/SOP/029 “Out of Specification Procedure forNon-Conforming Materials and Drug Products (Analytical Tests)}” doesnot ensure satisfactory conformance to batch release specifications ; and appropriate investigation and tracking ofOOS events, because it is internally inconsistent and not clear.
3Other quality system
Handling ofin-process samples is inadequate.
4Other quality system
There isalackofQuality oversight in‘the'review ofprocédures followed in thequality control testing of “4 drug substance and drug product.
5Deviation, CAPA, and investigation
Deviations are not initiated and/or closed in time, per the deviation SOP, and do not include appropriate — justificationsfor delays in closure.
About this record
Extracted automatically from the document US FDA published on 2017-05-09. 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.
