# FDA 483 - VALENCIA NATURALS, INC - May 11, 2022

Source: https://www.globalkeysolutions.net/records/483/valencia-naturals-inc/6140f416-0a35-4d74-ab2c-b54b402476c2

> FDA 483 for VALENCIA NATURALS, INC on May 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VALENCIA NATURALS, INC
- Inspection Date: 2022-05-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: VALENCIA NATURALS, INC, a Class II medical device manufacturer of personal lubricants in Chatsworth, CA, was cited for three observations during an FDA inspection. The firm failed to maintain complete design history files and adequately document design risk analyses for its personal lubricant products. Additionally, the company did not establish proper quality supplier agreements with its contract manufacturer.

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- [483 - 2025-06-02](https://www.globalkeysolutions.net/records/483/valencia-naturals-inc/aff04d1b-b5b5-47c1-8d9c-cc230a8f1bad)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/valencia-naturals-inc/5ec10708-ee1b-4ee6-9052-f2184a012ef8

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