August 29th 2025
The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
Expanded FluMist Indication Delayed by cGMP Violations
June 21st 2007The FDA issued MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com), a warning letter for violating the agency's manufacturing rules and held off approving the company's influenza vaccine for use in children younger than age five until the problems are resolved.