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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
An operator removed plexiglass drum covers used to protect the product during manufacturing and placed the covers outside the controlled HEPA airflow area. Read More