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

Source: https://www.keypedia.com/records/483/quagen-pharmacuticals-llc/c9fb6bc0-9df1-4073-bab5-f0be6c3780b6

> FDA 483 for Quagen Pharmacuticals, LLC on November 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quagen Pharmacuticals, LLC
- Inspection Date: 2023-11-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)
- [Mayar M. Mussa](https://www.keypedia.com/people/mayar-m-mussa/4f39b1c8-93a6-4bc9-a800-5f802db48be6)

Company: https://www.keypedia.com/companies/quagen-pharmacuticals-llc/9f3a6bdf-7084-4753-aa36-3a336180eb8d

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248