483
Quagen Pharmaceuticals LLCQuagen Pharmaceuticals LLC – FDA 483, Nov 8, 2023
Record Details
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.
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ID · c9fb6bc0-9df1-4073-bab5-f0be6c3780b6
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