FDA Inspection 1283762 — Frontida Biopharm, LLC
The FDA completed an inspection of Frontida Biopharm, LLC on Oct 24, 2025 in Aurora, IL. 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 24, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aurora, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |