US Food and Drug Administration (USFDA) has conducted audit at Indoco Remedies’ sterile manufacturing facility in Verna, Goa (Plant II) from May 27, 2019 to June 04, 2019, issuing 4 observations (483s). These observations are procedural in nature, not pertaining to data integrity.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.