Life Science Outsourcing, Inc.November 12, 2020

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

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Record Details

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.

Company: Life Science Outsourcing, Inc.
Inspection Date: November 12, 2020
Product Type: Other
Office: Division of Pharmaceutical Quality Operations IV
Person: Truong X. Nguyen (Investigator)

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ID · f94e926f-482f-466d-a64f-8813a925036a