FDA Inspection 1269429 — Novus Surgical Solutions LLC
The FDA completed an inspection of Novus Surgical Solutions LLC on May 8, 2025 in Allentown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 8, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |