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 [...]
Blog Home TAG: FDA Warning Letters
In FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance ManagementPosted
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 [...]
In Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk ManagementPosted
First quarter 2017 Food and Drug Administration (FDA) warning letters emphasize a lack of effective document control system compliance. Two recent warning letters are patent examples. Both [...]
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