# FDA 483 - Orange Lab Holdings - July 19, 2024

Source: https://www.keypedia.com/records/483/orange-lab-holdings/eb199cea-dbdf-4a10-ab9e-b6db314a0942

> FDA 483 for Orange Lab Holdings on July 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orange Lab Holdings
- Inspection Date: 2024-07-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Orange Lab Holdings in Anaheim, CA, was inspected by the FDA, revealing significant and repeat deficiencies in their manufacturing of OTC drug and cosmetic products. The firm lacks adequate quality control procedures, has unvalidated cleaning and manufacturing processes, and exhibits poor control over computer systems and employee training. Additionally, there are failures in investigating out-of-specification results, maintaining equipment calibration, and adhering to a written stability program.

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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