JD Supra

Getting Form 483 responses right: FDA’s March 2026 draft guidance explained

In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to ...
FiercePharma

FDA slaps Dr. Reddy's Hyderabad biologics plant with seven observations in new Form 483

A June inspection now has the FDA hitting Dr. Reddy’s with a Form 483, with seven observations spotted at its Indian biologics plant in Hyderabad during a site visit that wrapped up this week. The ...
RAPS

FDA Sends Form 483s to Lupin, Aurobindo and Cipla Sites

Following inspections in late September, India-based generic drugmakers Lupin, Aurobindo and Cipla received Form 483s posted last week by the US Food and Drug Administration (FDA) for observations ...
FiercePharma

FDA flags 10 observations in another Form 483 for a Zydus plant

Zydus Lifesciences recently received its second Form 483 reprimand from the FDA within the span of one month. In the second write-up, the regulatory agency flagged issues ranging from unqualified ...
JD Supra

FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The guidance is intended for ...
Yahoo Finance

Alvotech (ALVO) Receives FDA Form 483 Following Routine Facility Inspection

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