FDA Inspection
Suzhou Xishan Zhongke Drug R&D, Co. Ltd.Suzhou Xishan Zhongke Drug R&D, Co. Ltd. – FDA Inspection, May 10, 2024
Record Details
This FDA Inspection record concerns Suzhou Xishan Zhongke Drug R&D, Co. Ltd., with an inspection on May 10, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 6ce9003a-7162-444d-9440-b96289a68b36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1240347
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 58.35(b)(3)QAU: problems affecting study integrity
- 21 CFR 58.51Facility: archives
- 21 CFR 58.63(a)Equipment: inspection, cleaning and maintenance
- 21 CFR 58.81(a)SOPs: laboratory methods
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.