FDA Inspection 1182088 — Randy J. Epstein, M.D.
The FDA completed an inspection of Randy J. Epstein, M.D. on October 26, 2022 in Highland Park, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 26, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Highland Park, IL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |