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# Cipla Limited FDA-483
- URL: https://www.fdaweb.com/cipla-limited-fda-483/
- Published: 2018-10-23T12:00:00.000Z
- Updated: 2026-09-15T00:40:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142648

FDA has released the FDA-483 issued following a 9/24-9/28 inspection at Cipla Limited, a Goa, India, drug manufacturer. The two inspection [observations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM623963.pdf?ref=fdaweb.com) were: 

- batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing; and
- written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.