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The FDA has slapped Polydrug Laboratories’ Mumbai facility with a warning letter for alleged GMP deviations seven months after it received a ban on U.S. imports. Read More
Xellia Pharmaceuticals and the FDA have agreed on a modified consent decree so Xellia can resume manufacturing at the Bedford, Ohio, site it purchased from Ben Venue Laboratories. Read More
The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations. Read More
The FDA has zeroed in on five dietary supplement makers in recent weeks, complaining of a laundry list of issues that range from promotional claims to GMP problems. Read More
Four foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
The FDA is looking to shed light on the sometimes murky rules governing compounding operations to distinguish heavily regulated outsourcing facilities from tiny compounding operations that are lightly regulated. Read More
The list of Chinese pharmaceutical companies in the FDA’s crosshairs keeps on growing, with the agency hitting two drugmakers for GMP violations and another for refusing an inspection. Read More
A second FDA inspection of niche drugmaker Sri Krishna after almost 10 years has turned up a bevy of complaints regarding the company’s quality control systems and the accuracy of its data. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More