# FDA 483 - George R. Reiss, MD - September 29, 2016

Source: https://www.globalkeysolutions.net/records/483/george-r-reiss-md/e6ae7d95-1f3f-4d4a-9ec1-d251dc73b988

> FDA 483 for George R. Reiss, MD on September 29, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: George R. Reiss, MD
- Inspection Date: 2016-09-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of George R. Reiss, MD in Glendale, AZ, a clinical investigator, revealed issues with the accuracy of subject case history records and exposure to investigational devices. Specifically, discrepancies were found between case report forms and source records for subject data. This indicates a concern regarding data integrity in clinical trial documentation.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/michelle-j-hines/c8087e41-6b8a-4b9a-92ad-bba500ce6fee)

Company: https://www.globalkeysolutions.net/companies/george-r-reiss-md/262d06ce-562c-4f19-8fe0-289b6e11aaa8

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