# FDA 483 - Amylynne J. Frankel, M.D. - May 28, 2025

Source: https://www.globalkeysolutions.net/records/483/amylynne-j-frankel-md/efef0053-f192-44f9-a085-f541591f5cfb

> FDA 483 for Amylynne J. Frankel, M.D. on May 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amylynne J. Frankel, M.D.
- Inspection Date: 2025-05-28
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Advanced Dermatology & Cosmetic Surgery in Spartanburg, SC, a clinical investigator site, revealed significant deficiencies in conducting an investigational study. Observations included failure to follow the investigational plan regarding subject photographs and adverse event evaluation, inadequate case histories with missing clinical assessments, and poor investigational drug accountability and temperature monitoring. These issues indicate a lack of adherence to good clinical practice.

## Related Officers

- [Deborah A. Greco](https://www.globalkeysolutions.net/people/deborah-a-greco/38e393b5-55c4-461c-a0b0-4937e0cbec37)

Company: https://www.globalkeysolutions.net/companies/amylynne-j-frankel-md/9fbf941a-25b5-470b-b7b2-105aa1f9eacb

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7