2 Day FDA Inspections Readiness Webinar: What to Expect, How to Prepare & Avoid 483 Observations (LIVE EVENT & ON-DEMAND: May 13th - May 14th, 2026)

The primary market opportunities lie in equipping professionals with practical skills for preparing, managing, and responding to FDA inspections. This training addresses common challenges and ...
RAPS

FDA drafts guidance on best practices for responding to inspection observations

The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
JD Supra

FDA Issues Draft Guidance on Responding to FDA Form 483 Observations Following Drug Inspections

On March 6, 2026, the Food and Drug Administration (“FDA” or “the Agency”) issued a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The draft ...
JD Supra

FDA’s Draft Guidance for Cosmetics Industry Explains Records-Access Authority During Inspections

The U.S. Food and Drug Administration (FDA) has issued a draft guidance reminding the cosmetics industry that the agency can access a variety of business records ...
RAPS

FDA Drafts Guidance on Inspections of Medical Device Establishments

The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA ...