# FDA 483 - Life Science Outsourcing, Inc. - November 12, 2020

Source: https://www.globalkeysolutions.net/records/483/life-science-outsourcing-inc/f94e926f-482f-466d-a64f-8813a925036a

> FDA 483 for Life Science Outsourcing, Inc. on November 12, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Life Science Outsourcing, Inc.
- Inspection Date: 2020-11-12
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Life Science Outsourcing, Inc. in Brea, CA, a contract sterilizer, received a Form 483 with three observations during an FDA inspection. The inspection revealed deficiencies in computer system controls for quality and production records, inadequate laboratory sampling plans for the water system, and insufficient control and reconciliation of master production and control records. These issues indicate a lack of robust data integrity and quality control practices.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

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