# FDA 483 - COLONIAL DAMES CO LTD - April 12, 2023

Source: https://www.keypedia.com/records/483/colonial-dames-co-ltd/782e89a7-68a7-4dc5-8ec0-0bf47c373b47

> FDA 483 for COLONIAL DAMES CO LTD on April 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: COLONIAL DAMES CO LTD
- Inspection Date: 2023-04-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of COLONIAL DAMES CO LTD in Commerce, CA, revealed significant deficiencies in their manufacturing practices for drug products. The firm failed to implement adequate cleaning validation, qualify its water system, investigate out-of-specification results, and establish proper quality agreements. Additionally, the company lacked annual product reviews and a written stability testing program, indicating a broad failure to adhere to cGMP regulations.

## Related Documents

- [483 - 2021-04-29](https://www.keypedia.com/records/483/colonial-dames-co-ltd/a819bd18-032f-4cdd-b559-56810fbf57e5)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)

Company: https://www.keypedia.com/companies/colonial-dames-co-ltd/a6246cee-35cc-4d50-88b6-2639a00bd189

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