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# FDA Releases Biocon Inspection 483
- URL: https://www.fdaweb.com/fda-releases-biocon-inspection-483/
- Published: 2017-05-11T12:00:00.000Z
- Updated: 2026-09-14T22:23:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138668

FDA has released the FDA-483 issued following a 3/27-4/7 agency inspection at Biocon Limited, Bangalore, India. Specific [violations](ttps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM557440.pdf) were: 

- discrepancies between information submitted in an undisclosed document and the manufacturing process at the facility;
- the company quality assurance unit has approved and implemented documents that do not assure appropriate production, testing, and deviation review and release of commercial material;
- inadequate handling of in-process samples;
- lack of quality oversight in the review of procedures followed in the quality control testing of an unidentified drug substance and drug product;
- The out-of-specification (OOS) procedure for non-conforming materials and drug products does not ensure satisfactory conformance to batch release specifications and appropriate investigation and tracking of OOS events because it is internally inconsistent and not clear;
- unidentified solutions for drug substance formulation do not have adequate microbial control;
- bioburden sampling during manufacturing of an unidentified drug product is inadequate; and
- deviations are not initiated and/or closed in time per the deviation standard operating procedure and do not include appropriate justifications for closure delays.