FDA Inspection 1067624 — Brio Pharmaceuticals Inc
The FDA completed an inspection of Brio Pharmaceuticals Inc on October 3, 2018 in Houston, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 3, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Over-the-Counter Drug Evaluation
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |