# FDA 483 - Next Orthosurgical Inc - August 09, 2024

Source: https://www.keypedia.com/records/483/next-orthosurgical-inc/cc5a26cc-0ff4-4e86-b9d3-a7f843d4fade

> FDA 483 for Next Orthosurgical Inc on August 09, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Next Orthosurgical Inc
- Inspection Date: 2024-08-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Next Orthosurgical Inc, a medical device manufacturer in Vista, CA, revealed three significant quality system deficiencies. The firm failed to adequately document process validation activities, maintain and revise device master records, and establish procedures for valid statistical techniques in quality control. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/next-orthosurgical-inc/6edb2323-0865-4fb1-9472-da67d06af06a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6