# FDA 483 - Promade POC Center for Complex Orthopedic Solutions at HHS - January 18, 2024

Source: https://www.keypedia.com/records/483/promade-poc-center-for-complex-orthopedic-solutions-at-hhs/78225da7-c2f1-4d9f-9891-5558152d1428

> FDA 483 for Promade POC Center for Complex Orthopedic Solutions at HHS on January 18, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Promade POC Center for Complex Orthopedic Solutions at HHS
- Inspection Date: 2024-01-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Promade POC Center for Complex Orthopedic Solutions at HSS, a medical device manufacturer in New York, identified one observation related to inadequate maintenance of device history records. The firm failed to properly record lot numbers and work instructions in their recycle blending records for titanium powder, and their device history records contained discrepancies regarding work instruction procedures. This indicates a moderate compliance issue with record-keeping practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/promade-poc-center-for-complex-orthopedic-solutions-at-hhs/2148f760-b246-4458-9d80-d43ee88839f8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961