The FDA communicated its concern to Cadila in a Form 483
Drug maker Cadila Healthcare has come under the US regulatory scanner with the US Food and Drug Administration (USFDA) expressing concern over the manufacturing process of at least one product at Cadila's Moraiya facility in Gujarat. The company will respond to the observations of the FDA, made after conducting a product specific inspection of its Moraiya manufacturing plant, a company spokeswoman said.
"This was a product specific review and the inspection was limited to the review of documents filed for ANDA before its approval and the observations are being responded to," a statement mentioned.
There is no business impact from the FDA action and Cadila has not received any observations on the standard manufacturing practices at the Moraiya plant, the spokesperson said.
The FDA communicated its concern to Cadila in a Form 483, the statement said. Once a Form 483 is issued by the FDA, the company has 15 days to respond before further action is taken.