What Happens After Your FDA Form 483 Response Submission?
November 26th, 2014 by Henry Macartney
[...] Read MoreUsing Audits To Improve Your Supplier Quality And Performance
March 19th, 2014 by James Francum
Supplier oversight and quality is imperative in [...] Read More
Understanding 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