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The FDA hit Hangzhou SunKing Nonwovens with a warning letter, citing the manufacturer for numerous quality violations at its Hangzhou, Zhejiang facility. Read More
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