FDA Inspection 1147132 — Richard J. Obiso, PhD dba Avila Herbals, LLC
The FDA completed an inspection of Richard J. Obiso, PhD dba Avila Herbals, LLC on July 26, 2021 in Christiansburg, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 26, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Christiansburg, VA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7270 | 21 CFR 56.103(a) | IRB review requirement |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7518 | 21 CFR 312.64(d) | Financial info |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7632 | 21 CFR 312.6(a) | Required label statement |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |