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

Source: https://www.keypedia.com/records/483/west-coast-cosmetics-inc/6cbcc29a-f2a6-4ce9-bb69-038af1d21acf

> 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: Los Angeles District Office
- Summary: During an inspection conducted from February 12 to March 15, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to West Coast Cosmetics Inc., an OTC Drug Manufacturer located in Chatsworth, CA. The inspection revealed several significant observations pertaining to the company's adherence to manufacturing quality standards, specifically Current Good Manufacturing Practices (CGMP).

A primary concern was the absence of an independent quality control unit. The Production Manager was noted to concurrently manage both production and quality functions, leading to insufficient separation of duties and inadequate procedures for defining quality responsibilities. This included a lack of quality oversight for employee training and a failure to conduct adequate annual product reviews, which was a repeat observation.

Further issues identified related to equipment and facility maintenance. The company's cleaning validation for manufacturing equipment was found to be inadequate, as it did not encompass OTC drug products and relied on an outdated cosmetic-focused validation from 2005. Additionally, procedures for cleaning and sanitization lacked a comprehensive list of approved agents. The water system used for drug manufacturing and equipment cleaning also lacked proper qualification and validation documentation.

Lastly, the inspection highlighted a deficiency in employee training, noting that personnel involved in manufacturing activities lacked documented current good manufacturing practices (CGMP) training. West Coast Cosmetics Inc. is required to address these observations by implementing comprehensive corrective actions to ensure compliance with regulatory standards.

## Related Documents

- [483 - 2022-03-09](https://www.keypedia.com/records/483/west-coast-cosmetics-inc/6bc4b934-4f37-42a5-ab0f-69e7bf5210c0)
- [483 - 2024-03-15](https://www.keypedia.com/records/483/west-coast-cosmetics-inc/6eea4b4f-28aa-4f09-8434-70e9437c0592)

## Related Officers

- [Steven J. Lynn](https://www.keypedia.com/people/steven-j-lynn/23c7bb25-33be-48e2-81fd-ab34c6096eac)
- [Consumer Safety Officer at FDA](https://www.keypedia.com/people/dianne-h-milazzo/3059779d-51f5-4622-8f8d-7766c76b47d5)
- [Professor of Medicine](https://www.keypedia.com/people/lawrence-r-deyton/92881ee2-c62d-4faf-b619-4900022cc779)
- [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/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b