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Employees were seen touching equipment or other surfaces outside of the ISO 5 area with gloved hands and then conducting aseptic processing in the cleanroom. Read More
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