# FDA 483 - Bio-Thera Solutions, Ltd. - January 17, 2025

Source: https://www.keypedia.com/records/483/bio-thera-solutions-ltd/9293d03a-2296-45c6-a9d9-857d59110ceb

> FDA 483 for Bio-Thera Solutions, Ltd. on January 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Thera Solutions, Ltd.
- Inspection Date: 2025-01-17
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Cosmetic Specialty Labs, Inc., a cosmetic manufacturer producing Over-the-Counter (OTC) drug products, was conducted from January 29 to February 8, 2024. The inspection revealed several significant deficiencies, many of which were repeat observations from a 2017 inspection, indicating a systemic lack of adherence to regulatory requirements.

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## Related Officers

- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)
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- [Jiangsong Jiang](https://www.keypedia.com/people/jiangsong-jiang/055e81c4-48a9-423d-b90f-ea0d08df79e1)

Company: https://www.keypedia.com/companies/bio-thera-solutions-ltd/a06cd8e7-9627-48bf-9f70-d2458bdc560b

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9