# FDA 483 - Sciegen Pharmaceuticals Inc - September 02, 2022

Source: https://www.keypedia.com/records/483/sciegen-pharmaceuticals-inc/500247d4-c1a2-41f6-9bee-15b0e37ef216

> FDA 483 for Sciegen Pharmaceuticals Inc on September 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sciegen Pharmaceuticals Inc
- Inspection Date: 2022-09-02
- 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, identified two significant observations. The firm's written procedures for equipment cleaning and maintenance were found to be inadequate, lacking sufficient detail for methods, materials, and sampling locations. Additionally, several pieces of automatic, mechanical, and electronic equipment, including coating machines used for Clopidogrel and Levetiracetam tablets, were not calibrated across their intended operating ranges.

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Investigator ](https://www.keypedia.com/people/sayyem-h-akbar/888c6b1b-7a62-4674-a73b-687c459db2f8)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

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