# FDA 483 - Life Science Outsourcing, Inc. - April 21, 2017

Source: https://www.globalkeysolutions.net/records/483/life-science-outsourcing-inc/6f99adf8-2e44-4c99-aa70-4e52db7ba1ce

> FDA 483 for Life Science Outsourcing, Inc. on April 21, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Life Science Outsourcing, Inc.
- Inspection Date: 2017-04-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Life Science Outsourcing, Inc. in Brea, CA, a contract sterilizer, received a Form 483 with six observations during an inspection from April 19-21, 2017. The observations primarily concern deficiencies in written procedures, employee training and qualifications, and equipment qualification and calibration, particularly related to biological indicator testing and laminar flow hoods. These issues indicate a lack of adequate controls to ensure the quality and sterility of drug products.

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## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.globalkeysolutions.net/companies/life-science-outsourcing-inc/5faf6cec-3776-4f5f-afcd-9848545f3ca9

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6