Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Glenmark Pharmaceuticals receives FDA warning letter for Indore facility, commits to resolving compliance issues promptly.

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging ...

Master FDA expectations and best practices. Learn about facility design, personnel qualification, and contamination control, tackling FDA scrutiny and aligning with EU Annex 1 & ICH Q9/Q10 principles.

The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Biotech deals involving assets developed in China are surging, a Jefferies report shows. | Biotech deals involving assets ...

Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and ...

U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder ...

The US Food and Drug Administration has issued 7 warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.