# FDA 483 - kdc/one Chatsworth, Inc. - March 24, 2023

Source: https://www.globalkeysolutions.net/records/483/kdcone-chatsworth-inc/a3bae9a4-7f3c-417f-9dc8-9b1b816e6924

> FDA 483 for kdc/one Chatsworth, Inc. on March 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: kdc/one Chatsworth, Inc.
- Inspection Date: 2023-03-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: kdc/one Chatsworth, Inc. in Chatsworth, CA, a manufacturer of cosmetics and OTC drug products, was inspected by the FDA from March 20-24, 2023. The inspection revealed significant deficiencies across multiple areas, including inadequate cleaning and sanitization of equipment, improper calibration of instruments, failures in quality control unit oversight, and poor documentation practices. Additionally, the firm was cited for late annual product reviews, insufficient GMP training, lack of proper warehousing procedures leading to temperature excursions, and inadequate handling of customer complaints.

## Related Officers

- [Stryker, Regulatory Affairs](https://www.globalkeysolutions.net/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

Company: https://www.globalkeysolutions.net/companies/kdcone-chatsworth-inc/891b01f9-8d35-4532-bb6c-1c208e4f2392

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