# FDA 483 - Veterans Administration Long Beach Healthcare System IRB - May 17, 2019

Source: https://www.globalkeysolutions.net/records/483/veterans-administration-long-beach-healthcare-system-irb/b04c73c9-110b-4eb2-a8f6-a2ec7e919c8c

> FDA 483 for Veterans Administration Long Beach Healthcare System IRB on May 17, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veterans Administration Long Beach Healthcare System IRB
- Inspection Date: 2019-05-17
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of the Veterans Administration Long Beach Healthcare System IRB identified a significant issue regarding recordkeeping. The facility failed to maintain copies of all research proposals reviewed and approved sample consent documents. This indicates a deficiency in the IRB's documentation practices for clinical investigations.

## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.globalkeysolutions.net/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)

Company: https://www.globalkeysolutions.net/companies/veterans-administration-long-beach-healthcare-system-irb/dd033f5e-0e6e-4287-8368-40a627f37479

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