# FDA 483 - Cosmetic Enterprises Ltd - June 11, 2021

Source: https://www.keypedia.com/records/483/cosmetic-enterprises-ltd/2386d7c8-fcd5-4789-b44a-04dd9e949f69

> FDA 483 for Cosmetic Enterprises Ltd on June 11, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmetic Enterprises Ltd
- Inspection Date: 2021-06-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Cosmetic Enterprises Ltd, a drug manufacturer in Pacoima, CA, was cited for multiple significant deficiencies across its production, quality, laboratory, and materials systems. Observations included a lack of written procedures for production controls, failure to follow reprocessing procedures, inadequate OOS investigations, and insufficient quality unit oversight. Additionally, the firm lacked appropriate computer system controls, sound laboratory specifications and sampling plans, proper laboratory record-keeping, and adequate validation of component supplier analyses.

## Related Documents

- [EIR - 2021-06-11](https://www.keypedia.com/records/eir/cosmetic-enterprises-ltd/bcbf89c5-6c30-4290-94d3-7ea1a3226d46)
- [483 - 2025-09-26](https://www.keypedia.com/records/483/cosmetic-enterprises-ltd/b0f7172c-0520-46d7-b7d5-4f2549ae9625)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Dogbeda F. Mackenzie](https://www.keypedia.com/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

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

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