# FDA 483 - TRUERELIEF - August 13, 2021

Source: https://www.globalkeysolutions.net/records/483/truerelief/9e66e899-6c50-4303-8e6d-d0fba5a2c636

> FDA 483 for TRUERELIEF on August 13, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRUERELIEF
- Inspection Date: 2021-08-13
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: TRUERELIEF in Santa Monica, CA, was inspected by the FDA from August 11-13, 2021, and received a Form 483. The inspection revealed a significant quality system deficiency related to design controls. Specifically, the firm failed to establish design plans for its medical device development activities, as demonstrated by issues with its Design History File.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/truerelief/097847a8-26a9-4bc2-9dd2-cf4f6a3c12b3

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