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The FDA issued its first warning letter under the Drug Supply Chain Security Act (DSCSA), hitting McKesson for violating verification requirements and allegedly shipping illegitimate product. Read More
The FDA hit Korean OTC drugmaker Soleo with a warning letter after finding significant CGMP violations during an Aug. 6-9, 2018 inspection of its Pyeongtaek-Si, Gyeonggi-do facility. Read More
The Italian Medicines Agency found serious GMP violations during an Oct. 31 inspection of a heparin manufacturing facility in China and recommended that the firm be prohibited from supplying crude heparin sodium to the EU. Read More
The FDA cited seven drug manufacturers for significant problems identified during inspections, ranging from inadequate testing to a failure to secure analytical equipment. Read More
The FDA hit Hangzhou Guogang Touring Commodity, an OTC drug manufacturer in Zhejiang, China, with a warning letter, for significant problems with equipment cleaning and drug product conformity. Read More
The FDA issued a warning letter to Akorn’s sterile drug manufacturing facility in Decatur, Illinois on Jan. 4 over poor aseptic conditions observed during an inspection last spring. Read More
The FDA hit Indian API manufacturer Malladi Drugs and Pharmaceuticals with an extensive Form 483 for multiple violations at its facility in Gajulamandyam, Andhra Pradesh. Read More
The FDA cited a Cardinal Health subsidiary for issues with equipment cleaning, conformity testing and other processes at its Fort Lauderdale, Fla., PET drug manufacturing facility. Read More