FDA Inspection
DELBio (Wujiang) Co., Ltd.DELBio (Wujiang) Co., Ltd. – FDA Inspection, Sep 12, 2024
Record Details
This FDA Inspection record concerns DELBio (Wujiang) Co., Ltd., with an inspection on September 12, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- DELBio (Wujiang) Co., Ltd.
- Inspection Date
- September 12, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 4e013414-d0ac-4efc-8a80-7c610c60c062
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1249760
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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.