FDA Inspection
Johnson & Johnson Medical (Suzhou) Ltd.Johnson & Johnson Medical (Suzhou) Ltd. – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns Johnson & Johnson Medical (Suzhou) Ltd., with an inspection on September 17, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 17, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ae4afcac-8533-4df8-b076-7879eec4dc85
Inspection Facts
- Inspection number
- 1337480
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.5.6Procedures for validation of processes lack required elements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Johnson & Johnson Medical (Suzhou) Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 24, 2023 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| April 20, 2017 | Not classified | Office of Inspections and Investigations | |
| March 26, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 14, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Johnson & Johnson Medical (Suzhou) Ltd.
- FDA Inspection 1244162 - 2024-06-28
- FDA Inspection 1218179 - 2023-08-24
- FDA Inspection 1017538 - 2017-04-20
- FDA Inspection 922761 - 2015-03-26
- FDA Inspection 861679 - 2013-11-14
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