FDA 483 - Quagen Pharmacuticals, LLC - November 08, 2023

An FDA inspection of Quagen Pharmaceuticals, LLC in West Caldwell, NJ, from November 6-8, 2023, identified a significant deficiency in the firm's post-marketing surveillance system. The company failed to establish written procedures for monitoring adverse drug experiences, specifically regarding its website's 'Contact Form' and social media accounts. This oversight led to the 'Contact Form' being offline and unmonitored for approximately six months.