# FDA 483 - Cosmetic Solutions LLC - September 21, 2023

Source: https://www.keypedia.com/records/483/cosmetic-solutions-llc/f97c33a3-c657-40a4-af25-d85ea57fdb3a

> FDA 483 for Cosmetic Solutions LLC on September 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmetic Solutions LLC
- Inspection Date: 2023-09-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Cosmetic Solutions, LLC in Boca Raton, FL, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to thoroughly investigate discrepancies, establish adequate laboratory controls, and maintain proper production and process control procedures. Additionally, the quality control unit did not fully exercise its responsibility to ensure CGMP compliance and product quality.

## Related Officers

- [Consumer Safety Officer, FDA](https://www.keypedia.com/people/conner-n-mann/626fec03-b389-435c-b038-376fcc0952ac)
- [Compliance Officer](https://www.keypedia.com/people/mark-w-rivero/a03c776a-f56c-4150-b14b-678cb1cb31e6)
- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/cosmetic-solutions-llc/870fed1a-5df3-4b5a-a5f8-a4d9680acac8

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6