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The FDA issued warnings to Indian API manufacturer Vikshara Trading and Investments over serious violations, including hindering the agency’s investigation, and to Huron Pharmaceuticals, citing quality documentation issues. 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
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