# FDA EIR - Sciegen Pharmaceuticals Inc - September 18, 2013

Source: https://www.keypedia.com/records/eir/sciegen-pharmaceuticals-inc/0ac6c06b-b069-480d-8d76-c8ef14f435d7

> FDA EIR for Sciegen Pharmaceuticals Inc on September 18, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Sciegen Pharmaceuticals Inc
- Inspection Date: 2013-09-18
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA pre-approval and cGMP inspection of Sciegen Pharmaceuticals Inc., located in Hauppauge, NY, was conducted from September 10 to September 18, 2013. This inspection, covering the company's Quality, Laboratory Control, Material, and Packaging & Labeling systems, followed compliance programs 7346.832 and 7356.002. The inspection was classified as "No Action Indicated" (NAI), meaning no significant deficiencies were found, and no FDA Form 483 was issued. This positive outcome builds upon a prior NAI classification for earlier pre-approval inspections. During the exit meeting, several discussion points were raised to enhance the company's operational controls. These included the need for a more comprehensive definition and procedure for out-of-trend (OOT) results, and developing written procedures for general chromatographic practices, ensuring critical instructions are formally documented and communicated. Additionally, periodic challenges for the newly qualified visual system on the packaging line were suggested, and the importance of documenting method development information in a written report was emphasized. These recommendations aim to further strengthen compliance and quality systems.

## Related Documents

- [EIR - 2018-03-16](https://www.keypedia.com/records/eir/sciegen-pharmaceuticals-inc/97b96d96-bcf3-4cd3-9989-1544618d657f)
- [483 - 2011-09-16](https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/1d284827-ee38-4511-b570-a5c012157fbc)
- [EIR - 2019-06-21](https://www.keypedia.com/records/eir/sciegen-pharmaceuticals-inc/4efb8eb0-db23-4e94-a8e6-55482a840592)
- [EIR - 2013-04-02](https://www.keypedia.com/records/eir/sciegen-pharmaceuticals-inc/5aec1fd7-2062-4d7f-9d73-8bb1608fcd87)
- [483 - 2021-12-20](https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/1634f312-1a9c-465b-9cc8-830b78799bbc)

## Related Officers

- [Biotechnology Specialist at FDA](https://www.keypedia.com/people/robert-c-horan/81b78f43-200d-4eaa-a586-fe2101759ffd)
- [other](https://www.keypedia.com/people/matthew-a-spataro/90a45bed-79f6-4200-abaa-da3902ebd577)

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d