# FDA 483 - Sciegen Pharmaceuticals Inc - April 17, 2023

Source: https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/e2f9042a-4ff1-46f0-bbb2-f2cb753419c1

> FDA 483 for Sciegen Pharmaceuticals Inc on April 17, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sciegen Pharmaceuticals Inc
- Inspection Date: 2023-04-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of ScieGen Pharmaceuticals Inc., an analytical laboratory in Hauppauge, NY, identified one observation. The firm was cited for failing to retain appropriate reserve samples for reference products used in an in vitro comparative dissolution study. This indicates a deficiency in their sample retention practices.

## Related Documents

- [483 - 2011-09-16](https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/1d284827-ee38-4511-b570-a5c012157fbc)
- [483 - 2015-01-09](https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/5e31791b-c59c-42d6-8153-31d0bd380825)
- [483 - 2021-12-20](https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/1634f312-1a9c-465b-9cc8-830b78799bbc)
- [483 - 2022-09-02](https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/500247d4-c1a2-41f6-9bee-15b0e37ef216)

## Related Officers

- [Pharmacologist at FDA](https://www.keypedia.com/people/xikui-chen/b320acb8-c976-4b42-bfdb-95b1701e7627)

Company: https://www.keypedia.com/companies/sciegen-pharmaceuticals-inc/814ff2a4-e264-431f-bffa-9932abda619d

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd