Alembic Pharmaceuticals has faced its share of challenges over the years, ranging from a plant fire to a drug recall. Now, the generics manufacturer is dealing with a new Form 483 from the FDA, which listed four observations after a 10-day inspection earlier this month.
The observations relate to a visit of Alembic's site in Panelav, Gujarat, India. The site is an oncology injectable formulation facility.
“None of the observations is related to data integrity, and management believes that they are addressable,” Alembic said in a Bombay Stock Exchange filing, noting that it is preparing to respond to the FDA “within the stipulated period.”
Alembic didn't reveal details behind the observations. The company released the filing just three days after the FDA completed its inspection on Oct. 14.
Alembic has been wracked with troubles in the several years, ranging from recalls to a plant fire.
Last year in March, a bottle of its 20-mg telmisartan tablets was found to contain the wrong dose. Its Bridgewater, New Jersey, operation issued a recall notice over the labeling mix-up.
Back in 2017, a fire at a plant in Algeria disrupted operations at an Alembic joint venture. No one was injured during the fire, and inventories were covered by insurance.
Meanwhile, this is not the first FDA Form 483 this week. Torrent Pharmaceuticals was also hit with a recent Form 483 citing three observations ranging from sanitary to operational issues.