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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
The FDA issued a flurry of Form 483s to drugmakers in the United States, Japan and India for issues ranging from inadequate record-keeping to cleanliness issues. Read More
Responses to internal audit reports are critical for GMP compliance because they fall under CAPA — so how a company responds to the findings of an internal audit is a key component of an effective audit. Read More
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