FDA 483 - Indoco Remedies Limited - February 28, 2023

Indoco Remedies Limited, a drug manufacturer in Verna, Goa, India, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in aseptic processing, including inadequate microbiological contamination prevention, environmental monitoring, and equipment maintenance. Additionally, laboratory controls for component testing were found to be lacking scientific soundness.