Cipla Plant Gets FDA Warning Letter
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.
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Suanfarma acquires an API manufacturing facility in Italy to accelerate its growth in Europe, while CapsCanada relocates its headquarters as part of its growth strategy. Meanwhile, Glenmark, Aurobindo and Cipla struggle with quality issues.
Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.
Responses to FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.