FDA Warning Letter Evaluation
Concept Heidelberg regularly splits FDA cGMP warning letter issues to their CFR reference and publishes statistics about most frequently found deviations. As in the past year, the list is headed by § 211.100, which refers to the creation, approval and handling of written procedures / deviations for the Subpart F – Production and Process Controls followed by §211.165 Testing and release for distribution Subpart I – Laboratory Controls.