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Warning Letters

FDA
Manufacturing

FDA issues Form 483s to Japanese, Indian drugmakers

Two Japanese drugmakers and another in India were hit with Form 483s from the FDA following inspections that uncovered a variety of problems.
Joseph Keenan Sep 10, 2024 8:50am
FDA

EyePoint's Yutiq production lands in the FDA's crosshairs

Aug 27, 2024 4:07pm
FDA

FDA rebukes troubled Eugia production site with a warning letter

Aug 19, 2024 8:10am
FDA

CDMO Brassica blasted in 4-observation FDA warning letter

Jul 24, 2024 9:25am
FDA

FDA slams Dr. Reddy's plants in India with a pair of Form 483s

Jun 25, 2024 8:10am
FDA stop sign

FDA slams Chinese API maker Sichuan Deebio with warning letter

Feb 22, 2024 9:10am
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