API In Ducts And Filters Led To Cipla’s First Drug GMP Warning Letter

Despite the stain on Cipla’s compliance record, the company leads on drug quality in India, with major concerns raised in only 3% of FDA inspections, compared to 11% generally.

Warning Rubber Stamp
Cipla Receives Its First Warning Letter • Source: Shutterstock

The US Food and Drug Administration chastised Cipla Ltd. for good manufacturing practice problems related to inadequate contamination safeguards at its site in Vernon, Goa, India, in a 25 February warning letter.

The firm’s high efficiency particulate (HEPA) filters and air ducts were not cleaned on a routine basis, leading to cross-contamination...

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