Date:
Wed, 06 May 2026 10:13:48 EDT
Content:
The U.S. Food and Drug Administration (FDA) has published a Form 483 following an inspection of Bio-Thera Solutions, Ltd., a biopharmaceutical manufacturer based in China. The documentation stems from a site visit that concluded in January 2025.
A Form 483 is issued by the FDA at the conclusion of an inspection when investigators observe conditions that may constitute violations of the Food, Drug, and Cosmetic Act. For Bio-Thera Solutions, this regulatory update provides insight into the agency’s assessment of the company’s manufacturing processes and quality control systems at their international facility.
Following the receipt of a Form 483, the company is typically required to provide a written response detailing a corrective action plan. While these observations do not represent a final agency determination of non-compliance, they highlight specific areas where the manufacturer must improve to meet current Good Manufacturing Practice (cGMP) standards.
Source: FDA CDER Electronic Reading Room
Link:
http://www.fda.gov/drugs/cder-foia-electronic-reading-room/bio-thera-solutions-ltd-01172025
Keywords:
FDA, Bio-Thera Solutions, Form 483, Pharmaceutical Manufacturing, China, GMP Compliance