FDA Inspection
Shanghai ISO Medical Products Co., Ltd.Shanghai ISO Medical Products Co., Ltd. – FDA Inspection, Nov 16, 2023
Record Details
This FDA Inspection record concerns Shanghai ISO Medical Products Co., Ltd., with an inspection on November 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4dd7c28a-a65b-4977-b3fe-08bae3524cfa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224750
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
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 | |
| June 15, 2017 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: 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 1015064 - 2017-06-15
- FDA Inspection 875671 - 2014-04-03
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