FDA Inspection 1237537 — American Behavioral Research Institute, LLC
The FDA completed an inspection of American Behavioral Research Institute, LLC on May 3, 2024 in Boca Raton, FL. 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
- May 3, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Boca Raton, FL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7428 | 21 CFR 312.53(c)(2) | Investigator CV or other statement of qualifications |
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7458 | 21 CFR 312.57(b) | Records of Financial Interests |
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7505 | 21 CFR 312.55(a) | Investigator brochure |