# FDA 483 - Maxx Ortopedics Inc - May 16, 2025

Source: https://www.globalkeysolutions.net/records/483/maxx-ortopedics-inc/768433ea-0ace-4081-bed9-1add460ea3a0

> FDA 483 for Maxx Ortopedics Inc on May 16, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maxx Ortopedics Inc
- Inspection Date: 2025-05-16
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Maxx Orthopedics Inc, a medical device manufacturer in Norristown, PA, was inspected from May 14-16, 2025. The inspection revealed a significant deficiency in the documentation and follow-up of corrective and preventive actions (CAPA). This indicates a moderate severity issue related to quality system implementation.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.globalkeysolutions.net/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.globalkeysolutions.net/companies/maxx-ortopedics-inc/9d3aa11f-202b-411f-88c4-a5e141944d9f

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