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Data analysis of defects in on-site food inspections by the U.S. Food and Drug Administration from 2020 to 2024
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Yan-Jie HUANG1, 2, Yan-Rong LI1, 2, Nan LI1, 2, Yang HOU1, 2, Yue WU1, 2, Li LI1, 2, *
Journal of Food Safety & Quality | 2026, 17(8) : 237 - 243
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Journal of Food Safety & Quality | 2026, 17(8): 237-243
• Special Topic: Food Safety Risk Monitoring and Assessment •
Data analysis of defects in on-site food inspections by the U.S. Food and Drug Administration from 2020 to 2024
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Yan-Jie HUANG1, 2, Yan-Rong LI1, 2, Nan LI1, 2, Yang HOU1, 2, Yue WU1, 2, Li LI1, 2, *
Affiliations
  • 1.Chinese Academy of Quality and Inspection & Testing, Beijing 100176, China
  • 2.Key Laboratory of Food Quality and Safety, State Administration for Market Regulation, Beijing 100176, China
doi: 10.19812/j.cnki.jfsq11-5956/ts.20251106002
Outline
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Objective

To analyze the common defects on inspection observations in on-site food inspections conducted by the U.S. Food and Drug Administration (FDA).

Methods

This study analyzed the inspection observations (also known as form 483) issued by the FDA on-site food inspections from 2020 to 2024, and the data on inspection observations that fail to meet the requirements of part 117 of title 21 of the Code of Federal Regulations, used the cited regulation clause numbers as the analytical dimension. Additionally, based on the content of warning letters, discussed and summarized the common defects found in food manufacturers during inspections, as well as the implications and recommendations for Chinese food manufacturing enterprises that exporting to the USA.

Results

FDA inspections revealed that, food manufacturers enterprises had a high incidence of defects in areas such as sanitary operations, processes and controls, hazard analysis, preventive control measures and personnel management. The FDA maintains continuous oversight of the implementation of corrective actions for inspection observations.

Conclusion

Food manufacturing enterprises exporting to the USA should promptly implement effective rectification and provide responses to identified defects, implement targeted continual improvements, continuously improve their food safety management systems and raise the level of quality management.

U.S. Food and Drug Administration  /  form 483  /  defects on inspection observations  /  warning letter  /  quality assurance
黄艳杰, 李彦蓉, 李楠, 侯阳, 武岳, 李立. 2020—2024年美国食品药品监督管理局食品现场检查缺陷数据分析. 食品安全质量检测学报, 2026 , 17 (8) : 237 -243 . DOI: 10.19812/j.cnki.jfsq11-5956/ts.20251106002
Yan-Jie HUANG, Yan-Rong LI, Nan LI, Yang HOU, Yue WU, Li LI. Data analysis of defects in on-site food inspections by the U.S. Food and Drug Administration from 2020 to 2024[J]. Journal of Food Safety & Quality, 2026 , 17 (8) : 237 -243 . DOI: 10.19812/j.cnki.jfsq11-5956/ts.20251106002
Appendix
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Year 2026 volume 17 Issue 8
8
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Article Info
doi: 10.19812/j.cnki.jfsq11-5956/ts.20251106002
  • Receive Date：2025-11-06
  • Online Date：2026-11-05
Article Data
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History
  • Received：2025-11-06
Funding
Affiliations
    1.Chinese Academy of Quality and Inspection & Testing, Beijing 100176, China
    2.Key Laboratory of Food Quality and Safety, State Administration for Market Regulation, Beijing 100176, China
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表12种不同金属材料的力学参数
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Family		 属数
Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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