RE:RE:USA Inflation Reduction Act (IRA) 2022 Re: Biotech and ChinaOctober 30, 2024 - FDA cites Chinese drug manufacturing company with multiple CGMP violations including:
... failure to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tianjin-darentang-jingwanhong-pharmaceutical-co-ltd-683619-10302024