# FDA 483 - kdc/one Chatsworth, Inc. - February 03, 2020

Source: https://www.globalkeysolutions.net/records/483/kdcone-chatsworth-inc/b444c7c0-01a4-40c5-8633-0d248f3fc141

> FDA 483 for kdc/one Chatsworth, Inc. on February 03, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: kdc/one Chatsworth, Inc.
- Inspection Date: 2020-02-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Brilliant International, Inc. in Chatsworth, CA, revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations. Observations included inadequate employee training, failure to follow complaint handling procedures, poor equipment maintenance leading to product spills, and incomplete laboratory records for reference standards. These findings indicate a need for comprehensive corrective actions to ensure product quality and safety.

## Related Documents

- [483 - 2018-05-25](https://www.globalkeysolutions.net/records/483/kdcone-chatsworth-inc/7d480026-5192-44f6-9350-20cbed9c8d9e)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.globalkeysolutions.net/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.globalkeysolutions.net/companies/kdcone-chatsworth-inc/0a00f380-d4f5-48b0-984c-fcae85b2f96e

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