USFDA raises a red flag for Cadila's ANDA application

US Food and Drug Administration (USFDA) has reportedly raised concerns about Cadila's at least one product, for which it has sought approval from the regulator. USFDA has issued a Form 483 to Cadila Health’s Moraiya facility in Gujarat with observations and seeking details related to Abbreviated New Drug Applications (ANDA) filed by the company in the US. However, according to the company, USFDA has not expressed concerns for its current operations at its Moraiya plant.
 
“This was a product-specific review and the inspection was limited to the review of documents for filed ANDA before its approval and the observations are being responded to. There are no good manufacturing practices (GMP)-related issues and as such, no business impact,” said a Cadila spokesperson. She added that the US FDA conducted the GMP-related audit at the company’s manufacturing plant in Moraiya in August 2013 and it was cleared.
 
Form 483, issued to a company by US FDA authorities, usually highlights deviations found during inspection, included lack of written procedures and process controls in the plant, lack of records, absence of training for employees etc. Once the Form 483 is sent, the company has 15 days to respond before the FDA takes any further action.
 
FOR COMPLETE REPORT READ: Cadila's Moraiya facility under US FDA lens