# FDA 483 - Elly R. Lee MD - July 29, 2013

Source: https://www.keypedia.com/records/483/elly-r-lee-md/09859284-7c62-4fc3-89ac-a9ff73945811

> FDA 483 for Elly R. Lee MD on July 29, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elly R. Lee MD
- Inspection Date: 2013-07-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Elly R. Lee, M.D., a clinical investigator in Irvine, CA, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to investigational plans and protocols, leading to subject enrollment errors and incomplete questionnaire administration. Additionally, the firm failed to prepare and maintain accurate case histories, with numerous discrepancies found between source documents and electronic case report forms for multiple subjects.

## Related Officers

- [Investigator](https://www.keypedia.com/people/alexandra-b-pitkin/5e123821-0dd9-4a0d-ba57-f781008cda34)

Company: https://www.keypedia.com/companies/elly-r-lee-md/c8f48923-d889-4ffe-b6e4-ff30017d4f7c

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