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# Cipla Virgonagar FDA-483 Released
- URL: https://www.fdaweb.com/cipla-virgonagar-fda-483-released/
- Published: 2019-07-31T12:00:00.000Z
- Updated: 2026-09-15T01:41:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144658

FDA has released the FDA-483 issued following a 7/15-7/19 inspection at the Cipla Virgonagar, India, active pharmaceutical ingredient (API) manufacturing site. The inspection observations were: 

- inadequate investigations into out-of-specification QC analytical results, related to finished API product quality failures;
- failing to adequately design, install, or qualify equipment used to control and monitor critical process parameters identified in the manufacture of APIs and API intermediates;
- preventive controls over the electronic inventory and warehousing management systems are not effectively established to prevent product mix-ups and ensure traceability for the life cycle of the material;
- process validations of API intermediates are not designed and executed in a manner consistent with the original change control proposals, using all equipment specified in the change control;
- stability studies performed to determine the expiry dates for finished APIs are not conducted in the same container closure system as the packing procedure specified in the batch records;
- written procedures for packaging operations are not established; and
- records were not made readily available during FDA inspection.