# FDA 483 - KDC/ONE SOCAL LABORATORIES, LLC - September 13, 2022

Source: https://www.keypedia.com/records/483/kdcone-socal-laboratories-llc/f9892359-bb4e-436f-b16d-698eb6a1408f

> FDA 483 for KDC/ONE SOCAL LABORATORIES, LLC on September 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KDC/ONE SOCAL LABORATORIES, LLC
- Inspection Date: 2022-09-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: KDC/ONE SOCAL LABORATORIES, LLC in Walnut, CA, was inspected and cited for significant deficiencies across its quality system, laboratory system, and facilities and equipment. The inspection revealed failures in quality control procedures, inadequate complaint handling, insufficient computer system controls, and a complete lack of equipment cleaning records. These issues indicate a systemic breakdown in maintaining proper manufacturing and control standards for drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)

Company: https://www.keypedia.com/companies/kdcone-socal-laboratories-llc/d02dae40-fdd7-4623-934b-cb99482e07c9

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