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What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by

FDA Warning Letter Form 483 ResponseSo you’ve received an FDA Form 483, but you were prepared. You completed a productive inspection close-out meeting and gained [...] Read More

Using Audits To Improve Your Supplier Quality And Performance

March 19th, 2014 by

Supplier AuditsSupplier oversight and quality is imperative in maintaining the integrity of your product as well as your brand. When done correctly by knowledgeable and experienced consultants, [...] Read More

Understanding How FDA Warning Letters Can Hinder Your Company

January 30th, 2014 by

FDA Warning LetterUnder 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 FDA to document concerns discovered during inspections.

The 483 states that it “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional [...] Read More