# FDA 483 - West Coast Cosmetics Inc - March 15, 2024

Source: https://www.keypedia.com/records/483/west-coast-cosmetics-inc/6eea4b4f-28aa-4f09-8434-70e9437c0592

> FDA 483 for West Coast Cosmetics Inc on March 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: West Coast Cosmetics Inc
- Inspection Date: 2024-03-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of West Coast Cosmetics Inc., an OTC drug manufacturer in Chatsworth, CA, revealed significant deficiencies in their quality system, equipment maintenance, and personnel training. Key issues include the absence of an independent quality control unit (a repeat observation), inadequate cleaning validation and procedures for manufacturing equipment, an unqualified water system, and a lack of documented CGMP training for employees.

## Related Documents

- [483 - 2022-03-09](https://www.keypedia.com/records/483/west-coast-cosmetics-inc/6bc4b934-4f37-42a5-ab0f-69e7bf5210c0)

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)
- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)

Company: https://www.keypedia.com/companies/west-coast-cosmetics-inc/6d3129c0-b7de-4b7c-b7ee-f115624a9b8e

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