FDA Inspection 1127247 — KDunn and Associates, P.A. dba HealthQuilt
The FDA completed an inspection of KDunn and Associates, P.A. dba HealthQuilt on August 13, 2020 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 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 |