FDA Inspection
SHANGHAI HUBANG INTELLIGENT REHABILITATION EQUIPMENT CO.,LTDSHANGHAI HUBANG INTELLIGENT REHABILITATION EQUIPMENT CO.,LTD – FDA Inspection, Sep 4, 2025
Record Details
This FDA Inspection record concerns SHANGHAI HUBANG INTELLIGENT REHABILITATION EQUIPMENT CO.,LTD, with an inspection on September 4, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 4, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · fae1e648-e9eb-4fe1-8556-d6887e1d9f61
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1281376
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 820.198(a)Lack of or inadequate complaint 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.