FDA Inspection 1263062 — Intertek USA Inc.
The FDA completed an inspection of Intertek USA Inc. on March 7, 2025 in Whitehouse, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 7, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Whitehouse, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |