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# 11 Observations from Zhejiang Bangli Inspection
- URL: https://www.fdaweb.com/11-observations-from-zhejiang-bangli-inspection/
- Published: 2017-07-11T12:00:00.000Z
- Updated: 2026-09-14T22:33:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139109

FDA has released the FDA-483 from an 8/16-17/2016 agency inspection at Zhejiang Bangli Medical Products Co., Yongkang City, China. The [report](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM566017.pdf?ref=fdaweb.com) contains these 11 inspection observations: 

- there is no quality unit;
- production batch records do not include complete data;
- there is no final disposition decision for finished drug products;
- there is no document control program;
- distribution procedures are inadequate;
- batch records were not made available for review;
- in-process controls are inadequate;
- drug products are manufactured in insanitary conditions;
- there is no practice of labeling active pharmaceutical ingredients;
- manufacturing equipment is not maintained appropriately; and
- training practices are inadequate.