FDA Inspection 1301896 — Nexus Pharmaceuticals, LLC
The FDA completed an inspection of Nexus Pharmaceuticals, LLC on Jun 4, 2026 in Lincolnshire, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 4, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lincolnshire, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |