Warning Letters

FDA
Manufacturing

Aurobindo discloses FDA Form 483 at North Carolina inhaler plant

Aurobindo's Aurolife Pharma received an FDA Form 483 outlining 11 observations at a North Carolina plant, the Indian drugmaker said late last week.
Joseph Keenan 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
FDA

FDA slams Indian drugmaker Unexo with warning letter

Nov 20, 2024 9:25am
Novo

FDA scrutinizes Novo on production issues at semaglutide plant

Oct 31, 2024 9:33am