# FDA 483 - VIRTUS PHARMACEUTICALS LLC. - February 01, 2018

Source: https://www.keypedia.com/records/483/virtus-pharmaceuticals-llc/226e740f-d0be-4608-8930-04e8506d61c4

> FDA 483 for VIRTUS PHARMACEUTICALS LLC. on February 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VIRTUS PHARMACEUTICALS LLC.
- Inspection Date: 2018-02-01
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of VIRTUS PHARMACEUTICALS LLC. in Newtown, PA, revealed significant deficiencies in their pharmacovigilance system. The firm failed to establish written procedures for handling adverse drug experiences and repeatedly submitted periodic adverse drug experience reports (PADERs) late or not at all for multiple products. These issues indicate a systemic failure to comply with regulatory requirements for post-marketing safety surveillance.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/anastasia-offordile/299aed81-16f8-413e-a318-2d7f741957da)

Company: https://www.keypedia.com/companies/virtus-pharmaceuticals-llc/fd444690-bbba-4ca8-830f-4c695b01f462

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8