# FDA 483 - KDC/ONE SOCAL LABORATORIES, LLC - April 14, 2026

Source: https://www.keypedia.com/records/483/kdcone-socal-laboratories-llc/876ee0f8-b4d4-4261-a384-eb115e12a0d6

> FDA 483 for KDC/ONE SOCAL LABORATORIES, LLC on April 14, 2026. 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: 2026-04-14
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: KDC/ONE SOCAL LABORATORIES, LLC in Walnut, CA, a contract manufacturer, was cited for significant deficiencies in its quality control, stability testing, and equipment cleaning practices during an FDA inspection. Observations included inadequate testing of raw materials, failure to conduct ongoing stability studies and annual reserve sample examinations, and poor documentation and execution of equipment cleaning. A mixing tank marked as "cleaned" was found with visible residue, indicating a lack of control over critical manufacturing processes for OTC drug products.

## Related Documents

- [483 - 2022-09-13](https://www.keypedia.com/records/483/kdcone-socal-laboratories-llc/f9892359-bb4e-436f-b16d-698eb6a1408f)

## Related Officers

- [Navneet Kaur](https://www.keypedia.com/people/navneet-kaur/23db67cc-7589-46f9-bbb9-930c0460500f)
- [Thuy Tram L. Nguyen](https://www.keypedia.com/people/thuy-tram-l-nguyen/b58f2445-728e-4f79-b7eb-4dfb7e982e25)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b