# FDA 483 - COLONIAL DAMES CO LTD - April 29, 2021

Source: https://www.globalkeysolutions.net/records/483/colonial-dames-co-ltd/a819bd18-032f-4cdd-b559-56810fbf57e5

> FDA 483 for COLONIAL DAMES CO LTD on April 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: COLONIAL DAMES CO LTD
- Inspection Date: 2021-04-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Colonial Dames Company Ltd in Commerce, CA, revealed critical deficiencies in their drug product manufacturing and quality control systems. The firm failed to conduct required finished product testing before release, lacked essential written procedures for quality operations like change control and investigations, and assigned expiration dates without supporting stability data. These findings indicate a significant lack of adherence to good manufacturing practices.

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