FDA Inspection 1087147 — QuVa Pharma, Inc.
The FDA completed an inspection of QuVa Pharma, Inc. on Apr 23, 2019 in Sugar Land, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 23, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sugar Land, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |