Mumbai, March 11 -- The on-site inspection was conducted from 3rd March 2025 to 7th March 2025 by investigators from the Bioresearch Monitoring Program (BIMO) and the Office of Study Integrity & Surveillance (OSIS) of the US FDA.
The inspection covered both clinical and bioanalytical phases of three Bioavailability and Bioequivalence (BA/BE) studies submitted by clients to the US Food and Drug Administration (FDA).
The facility received one Form 483 at the end of the inspection, to which a response will be provided within the required timeframe.
Aditi Kare Panandikar, MD, Indoco Remedies, "This is an exciting step in our journey of excellence and a validation of our adherence to applicable regulations and maintaining the highest standard...