FDA Inspection 1276828 — IntegraDose Compounding Services LLC
The FDA completed an inspection of IntegraDose Compounding Services LLC on Jul 25, 2025 in Shoreview, 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 25, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shoreview, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |