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Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 ...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FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...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

FDA slams Chinese API maker with warning letter on heels of issuing Form 483

Less than two weeks after posting a scathing Form 483 filing, the FDA slammed Chinese API maker Sichuan Deebio Pharmaceuticals with a warning letter (PDF) citing “significant deviations” in its ...
FiercePharma

FDA puts New Jersey drug ingredients maker Spectrum through the wringer in scathing Form 483

With observations ranging from dirty packing rooms to incomplete lab control records, Spectrum Laboratory Products’ new FDA manufacturing write-up reads like a guide on what not to do when producing ...