JD Supra

FDA Issues First-of-Its Kind Guidance on Expectations for Drug Manufacturing 483 Responses

Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 ...
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FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...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

Serial FDA offender Lupin lands 17-observation write-up at Indian biotech plant

Despite repeated manufacturing infractions this year, Lupin has found itself on the receiving end of yet another FDA rebuke. Following an October FDA inspection, Lupin’s biotech manufacturing facility ...
The Week

USFDA issues Form 483 with 4 observations to Piramal Pharma's Telangana unit

Piramal Pharma has said the US health regulator has issued Form 483 with four observations after inspecting its Telangana-based manufacturing plant. The US ...
Food Safety News

FDA releases more inspection documents from ByHeart infant formula plants

The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...
Hosted on MSN

Granules India shares in focus after US FDA flags observation at Telangana API facility

Shares of Granules India will be in focus on Monday after the company announced that its active pharmaceutical ingredient (API) facility in Telangana has received an observation from the US Food and ...