# FDA 483 - OrthoPediatrics Corp - August 18, 2023

Source: https://www.globalkeysolutions.net/records/483/orthopediatrics-corp/8e9be422-7c24-4bf3-aab9-252b57b9a02f

> FDA 483 for OrthoPediatrics Corp on August 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OrthoPediatrics Corp
- Inspection Date: 2023-08-18
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of OrthoPediatrics Corp in Warsaw, IN, revealed significant deficiencies in the firm's complaint handling system. Procedures for receiving, reviewing, and evaluating complaints were not adequately established. Issues included product being lost or scrapped before evaluation, inadequate documentation of investigation information, and failure to determine root causes for multiple complaints.

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/orthopediatrics-corp/9d79bd2b-a583-49e2-aa1c-0ff34f6d1207

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22