# FDA 483 - Cosmetic Enterprises Ltd - September 26, 2025

Source: https://www.keypedia.com/records/483/cosmetic-enterprises-ltd/b0f7172c-0520-46d7-b7d5-4f2549ae9625

> FDA 483 for Cosmetic Enterprises Ltd on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmetic Enterprises Ltd
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Cosmetic Enterprises Ltd in Pacoima, CA, a drug manufacturer, revealed numerous and significant cGMP deficiencies, including several repeat observations. The firm failed to establish and follow written procedures for quality control, adequately control rejected components, verify raw material identity, and validate processes. Additionally, issues were noted with laboratory controls, investigation of out-of-specification results, equipment validation, stability testing, reserve sample retention, and computer system access controls.

## Related Documents

- [EIR - 2021-06-11](https://www.keypedia.com/records/eir/cosmetic-enterprises-ltd/bcbf89c5-6c30-4290-94d3-7ea1a3226d46)
- [483 - 2021-06-11](https://www.keypedia.com/records/483/cosmetic-enterprises-ltd/2386d7c8-fcd5-4789-b44a-04dd9e949f69)

## Related Officers

- [Gloria E. Andia](https://www.keypedia.com/people/gloria-e-andia/50f145fd-5e25-4a02-bc59-364bcb02b9c8)

Company: https://www.keypedia.com/companies/cosmetic-enterprises-ltd/a4179d0f-3a23-4585-b60d-47d78be143a1

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b