FDA Inspection 1304064 — Padagis US LLC
The FDA completed an inspection of Padagis US LLC on Apr 8, 2026 in Minneapolis, MN. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 8, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |