NMPA Center for Food and Drug Inspection issued the “Notice of Unannounced Inspections Results in 2nd batch of 2025” on August 15, 2025.
The unannounced inspections, also called surprise inspections or “fly inspections”, are carried out by provincial medical products administrations. This time it revealed widespread quality management weaknesses, including incomplete documentation, weak design controls, inadequate supplier oversight, and insufficient post-market vigilance. While most issues were categorized as general nonconformities, the recurrence of similar problems across multiple companies highlights systemic risks.
Worth mentioning is the only overseas manufacturer Beckman Coulter, whose fully automatic biochemical analyzer and specific protein analyzer are cited for missing maintenance records, inconsistent forms, incomplete standards, inadequate risk analysis, poor material risk classification, unclear electrostatic protection.
SaMD companies are experiencing extensive fly inspections. Click HERE for more information
Full List
Beckman Coulter (Jiangsu)
• Products: Automated biochemical and protein analyzers
• Findings: 6 nonconformities – no computer maintenance records, discrepancies in nonconformance forms, incomplete regulatory inputs, inadequate risk analysis, poor material classification, missing electrostatic protection requirements.
Shanghai Pinfeng Medical Technology Co., Ltd. (Zhengzhou Branch, Henan)
• Products: AFP and tPSA chemiluminescence kits
• Findings: 7 nonconformities – lack of UV lamp replacement requirements, missing heat-sealing parameters, incomplete design planning and risk management, missing analyzer metrology reports, incomplete inspection records, weak traceability of standards.
Yongcheng Technology Experimental Plant (Henan)
• Product: Medical glue
• Findings: 10 nonconformities – inadequate cleanroom pressure, inconsistent filter cleaning, UV lamps used excessively, insufficient risk identification, missing supplier management, unlabeled intermediates, incomplete sterilization and QC records.
Ningbo Botai Biotechnology Co., Ltd. (Zhejiang)
• Products: α-L-fucosidase kit, magnesium test kit
• Findings: 14 nonconformities – incomplete health checks, poor cleanroom humidity control, missing calibration/maintenance, obsolete procedures, errors in records, missing supplier reassessment, undefined storage, incomplete CAPA process.
Hunan Yinuosheng Medical Devices Co., Ltd. (Hunan)
• Products: Pulse oximeters, medical gas alarm systems
• Findings: 4 nonconformities – missing material records, no material classification, incomplete assembly records, inadequate final inspection.
Zhuhai Simai Technology Co., Ltd. (Guangdong)
• Product: Plasma bipolar electrosurgical system
• Findings: 11 nonconformities – overlapping responsibilities, incomplete documentation, missing sterilization validation, poor supplier audits, inadequate welding validation, vague acceptance criteria, weak data analysis and CAPA, missing audits after adverse events.
Qingdao Hantang Biotechnology Co., Ltd. (Shandong)
• Product: Mycoplasma pneumoniae IgM kit
• Findings: 5 nonconformities – incomplete training, missing cleaning validation, uncontrolled electronic records, poor change management, incomplete supplier audits.
Shandong Kanghua Biomedical Co., Ltd. (Shandong)
• Product: Mycoplasma pneumoniae IgM kit
• Findings: 9 nonconformities – incomplete training, poor equipment maintenance, outdated quality manual, inadequate records, incomplete document transfer, weak software management, frozen material risks.
Shenzhen Sky Original Biotechnology Co., Ltd. (Guangdong)
• Products: H1N1 and multiplex flu PCR kits
• Findings: 7 nonconformities – poor facility lighting, inadequate equipment calibration, outdated quality manual, incomplete design procedures, weak supplier contracts, poor inventory management.
Wuhan Zhongzhi Biotechnology Co., Ltd. (Hubei)
• Products: RSV and parainfluenza kits
• Findings: 3 nonconformities – poor material storage, undocumented SOPs, vague control strain procedures.
Tianjin Zhengtian Medical Devices Co., Ltd. (Tianjin)
• Product: Arthroscopy system
• Findings: 5 nonconformities – weak oversight of contractors, inadequate leakage current testing, altered records, improper rework, missing audits after failures.
Guangxi Weili Fangzhou Technology Co., Ltd. (Guangxi)
• Product: Infusion pumps
• Findings: 13 nonconformities – inconsistent qualification requirements, missing management reviews, inventory errors, poor calibration, incomplete and altered records, weak verification and software validation, ineffective supplier audits, poor customer feedback management.
Chengdu Yongxin Medical Equipment Co., Ltd. (Sichuan)
• Product: SPECT/CT imaging systems
• Findings: 7 nonconformities – production leaders unfamiliar with regulations, poor file management, incomplete design controls, missing change reports, inadequate procurement acceptance criteria.
Suzhou Yongxin Smart Manufacturing Medical Technology Co., Ltd. (Jiangsu)
• Product: SPECT/CT imaging systems
• Findings: 12 nonconformities – unqualified staff, inconsistent change control, incomplete contractor file validation, incorrect supplier records, poor outsourced material control, labeling errors, no static protection, incomplete inspections.
Beijing Baihui Weikang Technology Co., Ltd. (Beijing)
• Product: Neurosurgical navigation system
• Findings: 8 nonconformities – inventory mismatches, obsolete documents, missing design change records, supplier misclassification, weak process validation, incomplete inspection documentation.
Natong Biotechnology (Tianjin)
• Product: Arthroscopy system
• Findings: 4 nonconformities (1 major) – inexperienced managers, weak supplier contracts, inadequate QC testing, poor complaint handling.
