Novus Surgical Solutions LLC — FDA Facility Profile
Novus Surgical Solutions LLC is an FDA-inspected facility (FEI 3015342300) located in Allentown, PA, US. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 8, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 1 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 8, 2025 | Voluntary Action Indicated (VAI) | Calibration procedures and schedules (general) (21 CFR 1271.200(c)) |
| Apr 1, 2022 | Voluntary Action Indicated (VAI) | All core requirements covered in program (21 CFR 1271.160(a)) Quality audits performed periodically (21 CFR 1271.160(c)) Calibration procedures and schedules (general) (21 CFR 1271.200(c)) Contamination, mix ups, improper release (21 CFR 1271.260(a)) and 2 more |
Form 483s and inspection documents
- May 8, 2025: 483 on FDA.gov
Facility details
- Company
- Novus Surgical Solutions LLC
- Location
- Allentown, PA (US)
- Source
- inspections