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# CGMP Violations at India’s Cipla Limited
- URL: https://www.fdaweb.com/cgmp-violations-at-indias-cipla-limited/
- Published: 2020-03-17T12:00:00.000Z
- Updated: 2026-09-14T16:07:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146339

A 9/16-9/27/19 FDA inspection at Cipla Limited, Mumbai, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/25 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-597511-02252020?ref=fdaweb.com) says the specific violations were: 

- failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or established requirements;
- failing to thoroughly investigate any discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been distributed; and
- failing to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.

FDA acknowledges that the firm is suspending production on specified sterile units and says that remediating CGMP violations will be necessary before resuming drug manufacturing operations for the U.S. market.

Cipla was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completing the actions.