# FDA 483 - Advanced Cosmetic Research Laboratories, Inc. - July 24, 2023

Source: https://www.globalkeysolutions.net/records/483/advanced-cosmetic-research-laboratories-inc/e6078ebd-5610-45f2-ad5f-6801cbbe8920

> FDA 483 for Advanced Cosmetic Research Laboratories, Inc. on July 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Cosmetic Research Laboratories, Inc.
- Inspection Date: 2023-07-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Advanced Cosmetic Research Laboratories, Inc. in Chatsworth, CA, revealed significant deficiencies in their drug manufacturing operations. The firm was cited for a lack of qualified personnel, inadequate investigations into out-of-specification results, and premature batch record approvals. Additionally, issues included unvalidated cleaning processes, poor facility maintenance, absence of process validation, and insufficient testing and qualification of components and suppliers.

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## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Rowena S. Nguyen](https://www.globalkeysolutions.net/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

Company: https://www.globalkeysolutions.net/companies/advanced-cosmetic-research-laboratories-inc/d5c7ac58-0404-4683-aabb-483c74a7b86f

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