# FDA 483 - Sciegen Pharmaceuticals Inc - January 09, 2015

Source: https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/5e31791b-c59c-42d6-8153-31d0bd380825

> FDA 483 for Sciegen Pharmaceuticals Inc on January 09, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sciegen Pharmaceuticals Inc
- Inspection Date: 2015-01-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Sciegen Pharmaceuticals Inc. in Hauppauge, NY, revealed that the firm's quality control unit procedures were not fully followed. Specifically, a laboratory investigation into duplicate sample sets for Metformin Hydrochloride Tablets was deemed inadequate. The firm failed to determine the root cause of the event and did not conduct a comprehensive review of electronic files and associated audit trails.

## 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 - 2013-09-18](https://www.keypedia.com/records/eir/sciegen-pharmaceuticals-inc/0ac6c06b-b069-480d-8d76-c8ef14f435d7)
- [EIR - 2013-04-02](https://www.keypedia.com/records/eir/sciegen-pharmaceuticals-inc/5aec1fd7-2062-4d7f-9d73-8bb1608fcd87)

## Related Officers

- [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