Cadila Shifts US Injectables Production From Plant After Tough FDA Inspection

Expert investigators found many problems at Ahmedabad plant, warning letter and Form 483 report show.

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inspection raised concerns

Five months after a visit from a US inspection team that included sterile drugs expert Thomas Arista, Cadila Healthcare Ltd. informed the US Food and Drug Administration it would no longer produce injectable drug products for the US market at the facility in Village-Moraiya near Ahmedabad in western India’s Gujurat State.

The FDA noted Cadila’s plan to “permanently cease” such production in a warning letter it sent the firm on 29 October and published 12 November. The warning letter cautions...

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