# FDA 483 - Sciegen Pharmaceuticals Inc - September 16, 2011

Source: https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/1d284827-ee38-4511-b570-a5c012157fbc

> FDA 483 for Sciegen Pharmaceuticals Inc on September 16, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sciegen Pharmaceuticals Inc
- Inspection Date: 2011-09-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Sciegen Pharmaceuticals Inc. in Hauppauge, NY, was cited with two observations during a pre-approval inspection. The firm lacked scientifically sound laboratory controls for assigning expiry periods to volumetric solutions without stability data. Additionally, procedures were not established to prevent objectionable microorganisms, specifically concerning the purified water system's delivery hose.

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## Related Officers

- [Neil J. Bonzagni](https://www.keypedia.com/people/neil-j-bonzagni/67201e71-0bc0-45b8-b5f5-4c24d80b9325)
- [Biotechnology Specialist at FDA](https://www.keypedia.com/people/robert-c-horan/81b78f43-200d-4eaa-a586-fe2101759ffd)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961