# FDA 483 - Solevy Co. LLC - February 12, 2024

Source: https://www.globalkeysolutions.net/records/483/solevy-co-llc/8702522b-5508-4ae4-ac6c-5f010362e4df

> FDA 483 for Solevy Co. LLC on February 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Solevy Co. LLC
- Inspection Date: 2024-02-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Solevy Co. LLC, a Class II medical device manufacturer in Valencia, CA, was cited for two observations during an FDA inspection. The firm failed to establish unique device identifier (UDI) labeling requirements for its personal lubricant products. Additionally, design review results were not properly documented in the design history file, indicating deficiencies in quality system compliance.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/solevy-co-llc/3787ed8e-9657-4601-b706-a1b86215eb78

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