# FDA 483 - Novus Surgical Solutions LLC - May 08, 2025

Source: https://www.keypedia.com/records/483/novus-surgical-solutions-llc/5481db54-ff38-4371-be20-7c2fc6f37a1a

> FDA 483 for Novus Surgical Solutions LLC on May 08, 2025. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Novus Surgical Solutions LLC
- Inspection Date: 2025-05-08
- Product Type: other
- Office Name: FDA District Office — Philadelphia, Pennsylvania
- Summary: An FDA inspection of Novus Surgical Solutions LLC in Allentown, PA on May 8, 2025, revealed a significant issue regarding equipment calibration. The firm failed to implement and follow written procedures and schedules for the calibration of measuring equipment. This indicates a lapse in quality control practices.

## Related Documents

- [483 - 2022-04-01](https://www.keypedia.com/records/483/novus-surgical-solutions-llc/9cabea7a-9a96-4f19-8444-6abee8b3b8cf)
- [483 - 2025-05-08](https://www.keypedia.com/records/483/novus-surgical-solutions-llc/ab729aff-8dd1-4f18-959b-e79bf2f28cc5)

## Related Officers

- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/novus-surgical-solutions-llc/714da15a-718f-4e54-8892-d789159c6067

Office: https://www.keypedia.com/offices/fda-district-office-philadelphia-pennsylvania/e70a6e70-40b2-49e4-8360-c3db36c4d2a0