(Reuters) - India’s Alkem Labs Ltd said on Wednesday the United States Food and Drug Administration (USFDA) has issued a report about its Amaliya facility, citing 13 observations following an inspection.
The company said it is filing a response to the Form 483 observations about the facility in the western union territory of Daman and Diu, without disclosing details.
Shares fell as much as 10.4 percent, their biggest ever intra-day percentage loss.
Alkem has 16 manufacturing facilities, including 14 in India and two in the United States, the company website showed.
Reporting by Aby Jose Koilparambil in Bengaluru; Editing by Biju Dwarakanath