FDA Inspection 1252435 — Paradox, Inc
The FDA completed an inspection of Paradox, Inc on Oct 11, 2024 in Saint Joseph, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 11, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Joseph, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |