FDA Inspection
Shanghai ISO Medical Products Co., Ltd.Shanghai ISO Medical Products Co., Ltd. – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Shanghai ISO Medical Products Co., Ltd., with an inspection on June 15, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 15, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · fad22e2e-1562-4eb1-9353-0d1b7fbf1fe5
Inspection Facts
- Inspection number
- 1015064
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.40Procedures not adequately established or maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shanghai ISO Medical Products Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 22, 2026 | Not classified | Office of Inspections and Investigations | |
| November 16, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shanghai ISO Medical Products Co., Ltd.
- FDA Inspection 1332582 - 2026-07-22
- FDA Inspection 1224750 - 2023-11-16
- FDA Inspection 875671 - 2014-04-03
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.