United States Food and Drug Administration (USFDA) has completed inspection at Indoco Remedies’ manufacturing facility at Plant II (Sterile) located at Goa (Facility). The inspection was carried out from August 27, 2026 to September 4, 2026.
On conclusion of the inspection, the company received 7 observations in Form 483. The company is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.