# FDA 483 - Richard E. Ringel, M.D. - February 03, 2009

Source: https://www.globalkeysolutions.net/records/483/richard-e-ringel-md/af11fdda-e549-4600-9c93-814383e1d56f

> FDA 483 for Richard E. Ringel, M.D. on February 03, 2009. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Richard E. Ringel, M.D.
- Inspection Date: 2009-02-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Richard E. Ringel, M.D., a sponsor-investigator in Baltimore, revealed significant deficiencies in the conduct and oversight of an investigational clinical study for a medical device. The inspection found a lack of proper study monitoring, non-compliance with the investigational plan, and failure to obtain required signed agreements from participating investigators regarding supervision, informed consent, and financial disclosure. Additionally, the sponsor-investigator failed to submit current lists of investigators to the FDA at required intervals.

## Related Documents

- [483 - 2015-12-17](https://www.globalkeysolutions.net/records/483/richard-e-ringel-md/9d7e6053-24c3-42c0-8707-0626d05a0d5d)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephanie-l-shapley/5677033b-5e51-4a15-a8a7-53e73350d8e1)

Company: https://www.globalkeysolutions.net/companies/richard-e-ringel-md/f3011391-1f5b-4a50-b55b-11e1d1e8b091

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e