Date:
May 6, 2026
Content:
The U.S. Food and Drug Administration (FDA) has published a Form 483 detailing inspectional observations for Shouguang Fukang Pharmaceutical Co., Ltd., a manufacturing facility located in China.
Following an inspection completed on February 21, 2025, the FDA issued the report to document various conditions observed by investigators that may constitute violations of the Food, Drug, and Cosmetic Act. A Form 483 is a preliminary report that encourages management to take immediate corrective actions to address manufacturing or quality control concerns.
The release of this document through the Center for Drug Evaluation and Research (CDER) Electronic Reading Room is part of the agency’s commitment to transparency regarding international drug manufacturing oversight. This allows industry stakeholders and the public to monitor compliance with Current Good Manufacturing Practice (cGMP) standards for products intended for the U.S. market.
Source: FDA CDER FOIA Electronic Reading Room
Link:
http://www.fda.gov/drugs/cder-foia-electronic-reading-room/shouguang-fukang-pharmaceutical-co-ltd-02212025
Keywords:
FDA, Form 483, Shouguang Fukang Pharmaceutical, Pharmaceutical Inspection, China, CDER, cGMP Compliance