# FDA 483 - Cosmetic Science Laboratories, LLC - September 20, 2022

Source: https://www.keypedia.com/records/483/cosmetic-science-laboratories-llc/585b91a7-375b-4273-b8eb-f4caca99e3b1

> FDA 483 for Cosmetic Science Laboratories, LLC on September 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmetic Science Laboratories, LLC
- Inspection Date: 2022-09-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Cosmetic Science Laboratories, LLC, a contract manufacturer of over-the-counter drug products in Torrance, CA, revealed significant Current Good Manufacturing Practice (CGMP) deficiencies. The firm failed to establish adequate written procedures and controls for production, quality, laboratory, and equipment systems. Key issues included a lack of process and water system validation, incomplete batch records, insufficient component testing, and an absence of a stability testing program for its sunscreen products.

## Related Officers

- [Alan L. Truong](https://www.keypedia.com/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.keypedia.com/companies/cosmetic-science-laboratories-llc/8101dac1-7828-4fdf-9015-fa418014d696

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