Warning Letters

FDA
Manufacturing

Swedish contract manufacturer hit with FDA warning letter

Rechon Life Sciences received a warning letter from the FDA following a 2024 inspection that uncovered unsanitary conditions at its production plant.
Joseph Keenan 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
FDA stop sign

Aspen Pharmacare hit with warning letter citing sterility issues

Mar 20, 2025 9:45am
FDA

FDA hits 2 Indian API makers with warning letters, import alerts

Feb 20, 2025 9:05am
Warning letter

Viatris says India plant hit with FDA warning letter, import ban

Dec 23, 2024 10:50am