FDA Inspection 1283842 — Nelson Laboratories, LLC
The FDA completed an inspection of Nelson Laboratories, LLC on September 26, 2025 in Itasca, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Itasca, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |