Sun Pharma was slapped with a Form 483 that cited 10 observations following an inspection by the FDA at the company’s Halol manufacturing facility in Gujarat, India.
The action by the regulatory agency resulted from an inspection that began April 26 and ended Monday, Sun Pharma said in a filing with the Bombay Stock Exchange.
Details of the observations weren’t disclosed.
"The company is preparing the response to the observations, which will be submitted to the U.S. FDA within 15 business days,” Mumbai-based Sun said in the filing.
The agency issues a Form 483 at the conclusion of an inspection when its staff finds "objectionable conditions."
For India-based Sun, it follows a few other manufacturing mishaps in the last year. In October, Sun recalled more than 100,000 bottles of its generic tadalafil tablet for erectile dysfunction distributed in the U.S. after an "incorrect grade" of an inactive ingredient was found to have been added during production.
That recall came quick on the heals of Sun Pharma's move to pull 22,752 blister packs of its extended-release loratadine-D tablets because of "failed moisture limits," according to the FDA.