The United States Food and Drug Administration (USFDA) has conducted GMP inspection at Indoco Remedies’ Plant II (Sterile Facility) and Plant III (OSD Facility) at Goa. The inspection was conducted from February 20, 2023 to February 28, 2023.
The USFDA has issued Form 483 with four observations, which will be addressed within stipulated time. The company is committed to maintain compliances across all its facilities with cGMP quality standards at all times.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
