"United States Food and Drug Administration (USFDA) has issued a warning letter for company's site located at MIDC Chincholi, Solapur with reference to the observations of inspection performed in October, 2013," Smruthi Organics Ltd said in a filing to the BSE.
The company, which manufactures active pharmaceutical ingredients (API) for the regulated market, is working with USFDA in resolving the issues, it added.
Shares of the company were trading at Rs 52.70 a piece on the BSE, down 4.53% from its previous close.