# FDA 483 - Veterans Affairs Greater Los Angeles Healthcare System RDRC - September 06, 2019

Source: https://www.keypedia.com/records/483/veterans-affairs-greater-los-angeles-healthcare-system-rdrc/4d8c5099-28d5-4725-946c-aef1ed21b1d6

> FDA 483 for Veterans Affairs Greater Los Angeles Healthcare System RDRC on September 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Veterans Affairs Greater Los Angeles Healthcare System RDRC
- Inspection Date: 2019-09-06
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Veterans Affairs Greater Los Angeles Healthcare System RDRC in Los Angeles, CA, revealed a deficiency in record-keeping practices. The Radioactive Drug Research Committee (RDRC) failed to include the numerical results of votes on protocols involving human subjects in their meeting minutes from 2016 through 2019. This indicates a moderate severity issue related to documentation and oversight of research protocols.

## Related Officers

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

Company: https://www.keypedia.com/companies/veterans-affairs-greater-los-angeles-healthcare-system-rdrc/a2810e57-eda5-4201-af65-6cbe524efabb

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