Glenmark Gets Five Procedural Observations From US FDA

Glenmark Pharmaceuticals Ltd. on Wednesday said the US Food and Drug Administration made five procedural observations following a good manufacturing practices inspection at its Monroe facility in North Carolina, US, conducted from June 9 to June 17.

The observations were issued in a Form 483, the company said in an exchange filing, adding that none of them were related to data integrity.

A Form 483 is issued by the US FDA to highlight any objectionable conditions found during an inspection that may indicate violations of relevant laws. It serves as a prompt for companies to undertake corrective action.

Glenmark said it would respond to the observations within the prescribed timeline and work closely with the agency to resolve them.