FDA Inspection 1166498 — Novus Surgical Solutions LLC
The FDA completed an inspection of Novus Surgical Solutions LLC on April 1, 2022 in Allentown, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 1, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- 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 |