FDA Inspection 776737 — Arifulla Khan MD
The FDA completed an inspection of Arifulla Khan MD on March 28, 2012 in Bellevue, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Bellevue, WA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7229 | 21 CFR 50.27(b)(1) | Adequate opportunity to read before signing |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 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 |
| 7664 | 21 CFR 50.20 | Circumstances of obtaining consent |