# FDA EIR - Supernus Pharmaceuticals, Inc. - February 03, 2017

Source: https://www.keypedia.com/records/eir/supernus-pharmaceuticals-inc/8eedef50-ccfb-42f7-862f-6f8a5215ee59

> FDA EIR for Supernus Pharmaceuticals, Inc. on February 03, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Supernus Pharmaceuticals, Inc.
- Inspection Date: 2017-02-03
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA surveillance inspection of Supernus Pharmaceuticals, Inc. in Rockville, MD, was conducted from January 31 to February 3, 2017. The inspection focused on the company's Postmarketing Adverse Drug Experience (PADE) reporting program, governed by regulations such as 21 CFR 314.80(c)(2). The primary violation documented in an FDA Form 483 observation concerned the late submission of Periodic Safety Update Reports (PSURs). Supernus Pharmaceuticals failed to submit four PSURs for Trokendi XR and six PSURs for Oxtellar XR within the required 30-day timeframe after the close of the reporting quarter. These late submissions constituted approximately 40% of all PSURs filed for these products since their respective approvals. Additionally, management received verbal recommendations for improvement. These included an instance of a late 15-day adverse event report submission in 2014 (though corrected since transitioning to electronic submissions), a significant gap of 15 months where pharmacovigilance responsibilities with a licensing partner (Stendhal) were not formally documented, and the absence of a formal process to verify information extracted from source documents by their outsourced pharmacovigilance provider. The company's Vice President of Quality acknowledged the formal observation and committed to providing a written response within 15 business days.

## Related Documents

- [483 - 2017-02-03](https://www.keypedia.com/records/483/supernus-pharmaceuticals-inc/1869cce8-730f-465f-a5b7-3dae643d1f96)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/supernus-pharmaceuticals-inc/f2fae10b-5e77-4677-9772-90a2145ed69b)

## Related Officers

- [recipient](https://www.keypedia.com/people/frank-g-mottola/24bf0f27-30cc-446c-abf9-f4b02facf879)
- [Roshni J. Patel](https://www.keypedia.com/people/roshni-j-patel/362827f6-562d-4780-b641-9c4bf0e1097b)
- [investigator](https://www.keypedia.com/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)
- [company_representative](https://www.keypedia.com/people/lori-ann-sullivan/7adccd2d-3f5a-47e8-a9a4-3bc31f6390fe)
- [company_representative](https://www.keypedia.com/people/jack-a-khattar/ca9f8fc6-1d37-417c-ba01-284b90bc494e)

Company: https://www.keypedia.com/companies/supernus-pharmaceuticals-inc/eff1a996-667f-4888-9fd8-50ca50265d74

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c