FDA Inspection 1159513 — Daniel Fred Goodman, M.D.
The FDA completed an inspection of Daniel Fred Goodman, M.D. on December 13, 2021 in San Francisco, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 13, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Francisco, CA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7488 | 21 CFR 312.59 | Records of unused drug disposition |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |
| 7629 | 21 CFR 312.56(c) | Annual report |
| 7639 | 21 CFR 312.20(b) | Starting a study before IND is in effect |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |