Cadila Healthcare gets 14 USFDA observations for Moraiya plant
The US Food and Drug Administration (USFDA) inspected the plant from April 22, 2019 to May 3, 2019, Cadila Healthcare said in a regulatory filing.
New Delhi: Drug firm Cadila Healthcare Friday said the US health regulator has issued 14 observations after inspecting its manufacturing facility at Moraiya in Ahmedabad.
The US Food and Drug Administration (USFDA) inspected the plant from April 22, 2019 to May 3, 2019, the company said in a regulatory filing.
"The inspection concluded with 14 observations. There were no repeat observations or data integrity related observations," it added.
Prior to this, in September 2018, Cadila Healthcare's arm had received five observations from the US regulators. Medical Dialogues had reported that the inspection was made from August 20 to August 28, 2018. This was a product-specific Pre Approval Inspection. The inspection was concluded with 5 observations.
Also Read: Cadila Healthcare subsidiary gets 5 observations from USFDA
The company is headquartered at Ahmedabad in Gujarat state of western India. It is a manufacturer of generic drugs and was founded in 1952 by Ramanbhai Patel (1925–2001), formerly a lecturer in the L.M. College of Pharmacy, and his business partner Indravadan Modi.
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