# FDA 483 - Clean Cosmetics, LLC - August 19, 2022

Source: https://www.keypedia.com/records/483/clean-cosmetics-llc/145bc58f-b93c-483d-9457-90601dcc513b

> FDA 483 for Clean Cosmetics, LLC on August 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clean Cosmetics, LLC
- Inspection Date: 2022-08-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Clean Cosmetics, LLC in Moorpark, CA, a drug manufacturer, was cited for severe deficiencies in its quality control unit and overall manufacturing processes during an FDA inspection. The firm lacked a functional quality control unit, written procedures for critical operations, and adequate record-keeping, leading to the release of hand sanitizer products containing methanol without proper testing or batch control. These systemic failures indicate a significant lack of adherence to good manufacturing practices, posing potential risks to public health.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)
- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.keypedia.com/companies/clean-cosmetics-llc/1bf85e01-5286-4a53-a28f-f9e4cd0e070f

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