FDA Flags Serious GMP Violations at Indian Drug Manufacturer

In August 2025, the U.S. Food and Drug Administration inspected an Indian manufacturer of solid dosage medicines, Cohance Lifesciences Limited, and identified major Good Manufacturing Practice deficiencies. As a result, the agency classified the company’s products as non-GMP compliant.

A major concern involved poor handling of customer complaints about defective tablets. Several batches were reported as crumbly, pitted, and containing powder inside containers. The manufacturer initially concluded that the defects were “not confirmed,” later attributing them to a raw material. However, the FDA criticized the lack of analytical testing of retained samples and the absence of corrective actions or evaluation of other products using the same ingredient.

Inspectors also found serious issues with cleaning procedures for non-dedicated equipment. Visible contamination and residues containing multiple active ingredients suggested possible cross-contamination. The FDA further noted that the cleaning validation program, last conducted in 2018, failed to consider worst-case products or new medicines introduced later. Following the findings, the company agreed to temporarily suspend production.

04-03-2026