FDC Ltd had earlier announced regarding the U.S. Food and Drug Administration (FDA) inspection at company's manufacturing facility located at B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, from 6th February 2023 to 12th February 2023. FDA has determined that the inspection classification of this facility is "no action indicated" ("NAI"). Based on this inspection, this facility is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP).

FDA has concluded that this inspection is ''closed'' and a copy of the narrative portion of the Establishment Inspection Report (EIR) has been issued.