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483
•Bio-Thera Solutions, Ltd.•February 8, 2024

Bio-Thera Solutions, Ltd. – FDA 483, Feb 8, 2024

Record Details

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.

Company
Bio-Thera Solutions, Ltd.
Inspection date
February 8, 2024
Product type
drugs
Office
Dallas District Office
People
  • Yiwei Li
  • Jeanne Fringer (Chemist)
  • Nozomi Sakakibara (Senior Research Scientist)
  • Jiangsong Jiang
View Company Profile

ID · 9293d03a-2296-45c6-a9d9-857d59110ceb

Other documents for Bio-Thera Solutions, Ltd.
  • 483 - 2025-09-26September 26, 2025
  • 483 - 2025-01-17January 17, 2025
  • 483 - 2023-08-18August 18, 2023
  • 483 - 2017-10-06October 6, 2017

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