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# 10 Inspection Observations in Biocon ’483
- URL: https://www.fdaweb.com/10-inspection-observations-in-biocon-483/
- Published: 2017-08-08T12:00:00.000Z
- Updated: 2026-09-14T22:39:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139327

FDA has released the FDA-483 issued following a 5/25-6/1 inspection at Biocon, a Bangalore, Karnataka, India, sterile drug manufacturer. The 10 inspection observations on the [form](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM569851.pdf?ref=fdaweb.com) were: 

- investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed;
- laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards;
- procedures for cleaning and maintaining equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance;
- the firm’s quality control unit lacks the responsibility and authority to approve and reject all components and drug products;
- employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions;
- laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity; and
- procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.