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Getting Form 483 responses right: FDA’s March 2026 draft guidance explained

In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to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

CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued draft guidance Friday to standardize a mechanism for a medical device establishment to request ...
FiercePharma

FDA slams 3 Indian drugmakers in flurry of recent Form 483s

The FDA slammed three Indian drugmakers with Form 483s following recent inspections that uncovered unsanitary conditions, broken equipment and poor recordkeeping. Mumbai-based Alkem Labs was cited ...
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FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.”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