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USFDA issues 4 observations to Indoco Remedies’ Sterile facility at Goa

05 Jun 2023 Evaluate

The United States Food and Drug Administration (USFDA) has issued 4 observations in Form 483 to Indoco Remedies’ Sterile facility (Plant II) located at Goa. USFDA had inspected the said facility from February 20, 2023 to February 28, 2023. USFDA has determined the inspection classification of this facility as OAI (Official Action Indicated). The company is committed towards working with USFDA for remediation of the concerns on highest priority.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.

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