2017 Recap: FDA Warning Letter Observations and Trends
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 [...]
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TAG: CGMP Compliance
FDA Warning Letters: First Half of 2017 Trends
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 [...]
By AssurX
In FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management
Posted FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
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 [...]
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