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In 2017, the FDA released 476 warning letters. Top FDA warning letter violations were (1) adulterated products, (2) misbranded products, (3) insanitary conditions and (4) unapproved new [...]

The FDA released 225 FDA warning letters in the first half of the year. AssurX, a QMS software provider, provides a quick snapshot detailing the FDA’s activity. Top 3 FDA Warning Letter [...]

After a bit of a lull, the U.S. Food and Drug Administration (FDA) issued a batch of warning letters focused on pharmaceutical manufacturing quality issues in the first quarter of 2017. Examples [...]