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The FDA issued a Form 483 to drug manufacturer Amerigen for insufficient record-keeping and quality controls following a November 2016 inspection of the company’s Suzhou, China, facility. Read More
Drug manufacturer Gordon Laboratories received a Form 483 from the FDA for labeling problems, written procedure issues and insufficient analyses of raw materials. Read More
Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues. Read More