What is going on with AzaSite? It has been unavailable since late March. Thea has been completely unhelpful. Is it indifference? Incompetence? Perhaps it is the difference between running a small ...
As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these ...
A June inspection now has the FDA hitting Dr. Reddy’s with a Form 483, with seven observations spotted at its Indian biologics plant in Hyderabad during a site visit that wrapped up this week. The ...
Roughly a year after receiving an FDA reprimand at its manufacturing plant in Michigan, Indian drugmaker Piramal Pharma has landed in the regulator’s crosshairs once again. Following an inspection of ...
In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to ...
Glenmark Pharmaceuticals Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practice (GMP) ...
Glenmark Pharmaceuticals has received a Form 483 with six observations following a US FDA GMP inspection of its Goa ...
Following a 10-day inspection last October, the US Food and Drug Administration (FDA) sent a Form 483 with eight observations to Zimmer Biomet’s Detroit-based manufacturing site. The same site also ...
Another day brings more bad news for still-closed SanGar Fresh Cut Produce. This time it was the release of the FDA Form 483 report containing observations of the federal food safety inspectors who ...
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Dr Reddy's Laboratories' Hyderabad biologics facility received a Form 483 with seven observations following a USFDA ...
An FDA inspection can be nerve-wracking. Learn what two experts say you can do in person during an inspection to avoid receiving Form 483 observations or a warning letter. Marie Thibault For many ...
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