# FDA WARNING_LETTER - Colonial Dames Company, Ltd - April 12, 2023

Source: https://www.keypedia.com/records/warning_letter/colonial-dames-company-ltd/a2732f45-778a-4dea-8cb2-7678c44704f8

> FDA WARNING_LETTER for Colonial Dames Company, Ltd on April 12, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Colonial Dames Company, Ltd
- Inspection Date: 2023-04-12
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected Colonial Dames Company, Ltd. (FEI 2011035) in Commerce, CA, from April 4-12, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The "oxygenetix® (b)(4)" and "oxygenetix® Oxygenating Foundation Acne Control" products were cited as unapproved new drugs and misbranded. The company also failed to fulfill drug listing obligations.

Key violations include:
1.  **Inadequate Production and Process Controls (21 CFR 211.100(a)):** Manufacturing records lacked critical parameters (e.g., equipment ID, mixing speeds/times, component addition rates), and process validation documentation was absent.
2.  **Insufficient Equipment Cleaning and Maintenance (21 CFR 211.67(a) and (b)):** Cleaning procedures lacked validation, records were not maintained, and equipment/areas were unclean, a repeat observation from 2015 and 2021 inspections.
3.  **Unsuitable Equipment Design and Maintenance (21 CFR 211.63):** The water system used for drug manufacturing was not qualified, lacked monitoring, and showed increasing rust, despite prior commitments to use qualified vendor water.
4.  **Failure of Quality Control Unit (21 CFR 211.

## Related Officers

- [Yumi Hiramine](https://www.keypedia.com/people/yumi-hiramine/26c5059f-8f61-42cf-ae79-65a7b942d2c7)
- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)
- [Director of Investigations Branch](https://www.keypedia.com/people/katherine-e-jacobitz/9a713b44-95c4-43a2-83bb-8d30062d8345)

Company: https://www.keypedia.com/companies/colonial-dames-company-ltd/ab0a55c0-b4e3-4f8b-8fe3-65ac0893a8e7

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