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FDA issues 7 observations on Dr. Reddy's plant

Fierce PharmaRead the original26 Jun 2026

FDA issues 7 observations on Dr. Reddy's plant after inspecting its Hyderabad biologics facility, as noted in a new Form 483. This could delay approvals or trigger follow-up actions if not addressed promptly. While not a ban, it raises compliance concerns for the US-bound drugmaker. Seven observations signal moderate regulatory risk.

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