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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
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 investigator observed what appeared to be white residue and brown standing liquid inside a filling machine’s holding tank, which was supposed to be clean. Read More