FDA Inspection 1127247 — KDunn And Associates, P.A.
The FDA completed an inspection of KDunn And Associates, P.A. on Aug 13, 2020 in Houston, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 13, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Houston, TX (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7562 | 21 CFR 312.60 | Informed consent |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |
| 7659 | 21 CFR 50.25(a)(6) | Compensation, medical treatment in event of injury |
| 7665 | 21 CFR 50.20 | Exculpatory language, waiving of rights |