USFDA classifies Zydus Lifesciences Jarod unit as 'official action indicated'

Zydus Lifesciences Ltd has been classified as "official action indicated" by the US Food and Drug Administration (FDA) for its Jarod injectables manufacturing facility in Gujarat. The FDA's inspection, conducted between April 15 and 23, 2024, suggests the facility may withhold approval for pending product applications or supplements until outstanding observations are resolved.

from Healthcare/Biotech-Industry-Economic Times https://ift.tt/8hj1TuK
via IFTTT