Alkem Laboratories on Saturday said the US health regulator has issued two observations after inspection of its St Louis-based manufacturing facility.
The US Food and Drug Administration (USFDA) had conducted an inspection of the company's manufacturing plant at St Louis, USA from June 14-18, 2021.
At the end of the inspection, the company received Form 483 with two observations, Alkem Laboratories said in a regulatory filing.
The company shall submit to USFDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection, the drug firm said.
An FDA Form 483 is issued to a firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.
It notifies the company's management of objectionable conditions at the facility.
Alkem, which has operations spread across multiple territories abroad, produces a complete range of formulations of controlled substances at its finished dosage manufacturing facility in St Louis, Missouri.