Sun Pharmaceutical Industries has received 11 observations from the United States Food and Drug Administration (USFDA) after inspection of its Dadra facility. This inspection was completed on April 13, 2017. A Form-483 observation letter was issued by the USFDA post the inspection, listing 11 observations.
The company, however, did not provide any details about the observations made by the US health regulator.
The company and its subsidiaries have many facilities which supply products to the US market. These facilities undergo periodic routine inspection by the USFDA in normal course of business.
Sun Pharmaceutical Industries is an Indian multinational pharmaceutical company that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.
