# FDA 483 - Global Health Solutions LLC dba Turn Therapeutics - July 03, 2019

Source: https://www.globalkeysolutions.net/records/483/global-health-solutions-llc-dba-turn-therapeutics/78733c00-99b4-4584-a7ee-64a528931285

> FDA 483 for Global Health Solutions LLC dba Turn Therapeutics on July 03, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Health Solutions LLC dba Turn Therapeutics
- Inspection Date: 2019-07-03
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Global Health Solutions LLC dba Turn Therapeutics, a medical device manufacturer in Calabasas, CA, was inspected by the FDA. The inspection revealed a significant deficiency in their quality system, specifically the failure to establish design control procedures for their medical devices. This indicates a fundamental lack of documented processes for design and development activities.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/global-health-solutions-llc-dba-turn-therapeutics/9a6f5389-9cab-4439-a087-3075d8bfe58b

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