FDA Inspection 1166498 — Novus Surgical Solutions LLC
The FDA completed an inspection of Novus Surgical Solutions LLC on Apr 1, 2022 in Allentown, PA. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 1, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Allentown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |