# FDA 483 - Life Science Outsourcing, Inc. - December 11, 2025

Source: https://www.globalkeysolutions.net/records/483/life-science-outsourcing-inc/d20ddee8-014a-42c8-acac-cc585b83b520

> FDA 483 for Life Science Outsourcing, Inc. on December 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Life Science Outsourcing, Inc.
- Inspection Date: 2025-12-11
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Life Science Outsourcing, Inc. in Brea, CA, a contract sterilizer, was cited for significant deficiencies in its quality systems during an FDA inspection. Observations included inadequate sterilization process validation, failures in production and process control procedures, insufficient laboratory controls, and issues with equipment maintenance. The firm also failed to thoroughly investigate out-of-specification results and lacked scientific justification for invalidating bioburden findings.

## Related Documents

- [483 - 2017-04-21](https://www.globalkeysolutions.net/records/483/life-science-outsourcing-inc/6f99adf8-2e44-4c99-aa70-4e52db7ba1ce)
- [483 - 2020-11-12](https://www.globalkeysolutions.net/records/483/life-science-outsourcing-inc/f94e926f-482f-466d-a64f-8813a925036a)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Statistical Science Director](https://www.globalkeysolutions.net/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)

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

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b