The Dangers of Relying Solely on General Guidelines to Perform Software Validation for FDA Compliance
February 18th, 2014 by James Francum
[...] Read MoreUnderstanding How FDA Warning Letters Can Hinder Your Company
January 30th, 2014 by James Francum
Under the Federal Food, Drug and Cosmetic Act, SEC. 704 (21 USC §374) “Factory Inspection” the United States Food and Drug Administration (FDA) is authorized to perform inspections of US and foreign facilities. Form FDA 483 (Inspection Observations) is used by [...] Read More