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Aurobindo's manufacturing operations have once again landed the Indian drugmaker in hot water with the U.S. FDA. | ...
A Houston-based compounding pharmacy that was recently roped into Eli Lilly’s fight against knockoff GLP-1s has landed in the FDA’s crosshairs for the second time in less than a year. | The FDA has ...
FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward
In certain circumstances, manufacturers with prior open FDA inspections or enforcement letters (e.g., Form 483 observations or Warning Letters) may need to have these cleared and closed ...
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