# FDA 483 - Orange Lab Holdings - December 20, 2024

Source: https://www.keypedia.com/records/483/orange-lab-holdings/c45733e1-d98a-4cf4-9a5c-d25c9207d613

> FDA 483 for Orange Lab Holdings on December 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orange Lab Holdings
- Inspection Date: 2024-12-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Orange Lab Holdings in Anaheim, CA, revealed eight significant deficiencies in their manufacturing of OTC drug and cosmetic products. The firm demonstrated a pervasive lack of fundamental CGMP controls, including an absent quality control unit, unvalidated processes, and inadequate data integrity measures. Several critical issues were repeat observations from a previous inspection, highlighting persistent non-compliance.

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## Related Officers

- [Rachel C. Stanton](https://www.keypedia.com/people/rachel-c-stanton/36495725-366c-4138-a4d8-df3ce38fa9cd)

Company: https://www.keypedia.com/companies/orange-lab-holdings/6e4e0169-84f8-44f1-8f57-0f0886557ff8

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