# FDA 483 - Freedom Laser Therapy Inc - July 09, 2019

Source: https://www.keypedia.com/records/483/freedom-laser-therapy-inc/4242e940-7483-4f9b-aac1-331831f91918

> FDA 483 for Freedom Laser Therapy Inc on July 09, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Freedom Laser Therapy Inc
- Inspection Date: 2019-07-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Freedom Laser Therapy Inc., a medical device initial importer in Irvine, CA, identified a significant deficiency in its quality system. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements. This included a lack of completed or approved supplier evaluations and annual re-evaluations for the supplier of iRestore devices.

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/freedom-laser-therapy-inc/9974a60d-5bfc-4466-aa2b-7b4558d53827

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