# FDA 483 - OrthoGroup, Inc. - July 01, 2022

Source: https://www.globalkeysolutions.net/records/483/orthogroup-inc/5b410ba3-80c5-41c8-9003-fbf2b32a4d5b

> FDA 483 for OrthoGroup, Inc. on July 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OrthoGroup, Inc.
- Inspection Date: 2022-07-01
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: OrthoGroup, Inc. received an FDA Form 483 citing significant deficiencies across its quality system. The inspection revealed failures in establishing and implementing procedures for complaint handling, process validation, change control, device history records, purchasing controls, quality audits, management review, training, and document control. Additionally, the firm failed to maintain accessible and legible records, with some electronic records being corrupt.

## Related Officers

- [Linda Linh N Adams](https://www.globalkeysolutions.net/people/linda-linh-n-adams/7bc1bb60-951a-4d10-84b4-c105fc857171)

Company: https://www.globalkeysolutions.net/companies/orthogroup-inc/8396faba-ac4c-46e7-bdaf-c66f03411017

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b