The letter is based on the Corrective and Preventive Action submitted by Cadila to the observations raised by USFDA.
Chennai: Cadila Healthcare has received a warning letter from the US Food and Drug Administration (USFDA) with regard to its Moraiya formulation facility in Ahmedabad, following which the stock tumbled on Monday.
The letter is based on the Corrective and Preventive Action submitted by Cadila to the observations raised by USFDA. The USFDA inspection was conducted between April-22 and May-3, 2019 following which the regulator issued 14 observations relating to cleaning validation, out of specification and product contamination.
As per the company, there were no repeat observations or Data Integrity related observations. Subsequently, the US FDA accorded Moraiya facility as Official Action Indicated status in August 2019.
The US is a big market for Cadila, which contributes 40 per cent of total sales while Moraiya is an important facility accounting for 50 per cent of the US sales.