Expert investigators found many problems at Ahmedabad plant, warning letter and Form 483 report show.
Five months after a visit from a US inspection team that included sterile drugs expert Thomas Arista, Cadila Healthcare Ltd. informed the US Food and Drug Administration it would no longer produce injectable drug products for the US market at the facility in Village-Moraiya near Ahmedabad in western India’s Gujurat State.
The FDA noted Cadila’s plan to “permanently cease” such production in a warning letter it sent the firm on...
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
