Indoco Remedies Limited – FDA 483, Sep 4, 2026

Indoco Remedies Limited in Verna, India, received a Form 483 with seven observations following an inspection of its sterile drug manufacturing facility. The inspection revealed significant deficiencies in the firm's quality unit oversight, aseptic processing controls, environmental monitoring, and investigation practices, many of which are repeat observations from previous inspections and a Warning Letter. These issues collectively indicate a lack of adequate control over sterile manufacturing operations and a risk of microbiological contamination.