FDA Inspection 1263856 — QuVa Pharma, Inc.
The FDA completed an inspection of QuVa Pharma, Inc. on April 4, 2025 in Bloomsbury, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 4, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bloomsbury, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |