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FDA warning letter
Manufacturing
FDA rebukes two Indian API makers in pair of warning letters
The FDA slammed a pair of India-based API manufacturers in separate warning letters that outlined poor record-keeping and other problems.
Joseph Keenan
Jul 23, 2026 9:32am
Alembic site hit with warning letter on patient consent concerns
Jul 21, 2026 11:40am
Sanofi unit in Ireland dinged by FDA on Altuviiio production
Jul 1, 2026 2:52pm
Jubilant HollisterStier Montreal site gets FDA warning letter
Jun 25, 2026 8:08am
Medline earns FDA warning letter ire for repeat bacteria issues
Jun 4, 2026 7:36am
ImmunityBio responds to FDA warning letter with new protocols
Apr 6, 2026 3:10pm
