FDA inspection

Granules hit with FDA warning letter over production woes

Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in a new FDA warning letter.

Fraiser Kansteiner Mar 5, 2025 8:38am

inspection investigation FDA FDA inspection

FDA hits Piramal with 6-observation Form 483 at India API plant

Feb 26, 2025 10:22am

FDA hands out warning letters to 2 Chinese API manufacturers

Feb 11, 2025 2:30pm

FDA warning letter reveals production errors at Viatris plant

Jan 6, 2025 4:20pm

CRL complete response letter rejection FDA rejection

Zealand's hypoglycemia med rebuffed again by FDA

Oct 9, 2024 9:19am

FDA says it's taking steps to boost shortfall in inspections

Sep 20, 2024 8:35am