Warning Letters

FDA
Manufacturing

Indian API maker Cdymax hit with warning letter tied to testing

The letter comes in response to an earlier Form 483 the FDA issued after inspecting Cdymax's facility from April 21-25.
Joseph Keenan Nov 20, 2025 9:27am
FDA

FDA scolds Hetero over missteps at India warehouse

Oct 28, 2025 10:00am
FDA

Sun plant placed on FDA import alert over contamination issues

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