Warning Letters

FDA
Manufacturing

Sun plant placed on FDA import alert over contamination issues

Ongoing issues at Sun Pharma’s production facility in Gujarat, India, have resulted in the FDA putting the facility on import alert status.
Joseph Keenan Sep 11, 2025 9:25am
Warning letter

Hikal slammed with warning letter after contamination reports

Sep 11, 2025 8:07am
FDA stop sign

Amneal gets warning letter related to its antibacterial recalls

Sep 4, 2025 9:05am
FDA

Swedish contract manufacturer hit with FDA warning letter

Jun 9, 2025 9:09am
FDA stop sign

AACE Pharma slammed with FDA warning letter for CMO’s shortfalls

May 29, 2025 10:11am
FDA

Aurobindo discloses FDA Form 483 at North Carolina inhaler plant

Apr 14, 2025 3:00pm