# FDA 483 - Novus Surgical Solutions LLC - April 01, 2022

Source: https://www.keypedia.com/records/483/novus-surgical-solutions-llc/9cabea7a-9a96-4f19-8444-6abee8b3b8cf

> FDA 483 for Novus Surgical Solutions LLC on April 01, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novus Surgical Solutions LLC
- Inspection Date: 2022-04-01
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Novus Surgical Solutions LLC, a human tissue distributor in Allentown, PA, revealed significant deficiencies in its quality program. The firm failed to establish core Current Good Tissue Practice (CGTP) requirements, including quality audits, controlled storage areas, and procedures for product receipt and returns. Additionally, the firm lacked established procedures for equipment calibration.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/cara-minelli/23ac8da5-9b62-4be6-a258-54fab84fa646)

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

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8