# FDA 483 - OrthoSource Inc - January 26, 2023

Source: https://www.keypedia.com/records/483/orthosource-inc/c1257876-5fef-4e6b-b466-b9a05bc49553

> FDA 483 for OrthoSource Inc on January 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OrthoSource Inc
- Inspection Date: 2023-01-26
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: OrthoSource, Inc. in Van Nuys, CA was inspected by the FDA from January 24-26, 2023, revealing significant deficiencies. The inspection found that the firm lacked adequate procedures for finished device acceptance, specifically regarding bond strength testing for adhesive products. Additionally, the company failed to establish routine calibration, inspection, and maintenance procedures for manufacturing equipment, with no corresponding records.

## Related Officers

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

Company: https://www.keypedia.com/companies/orthosource-inc/266fbd9f-f725-44bd-98ef-4b90d9778031

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