FDA Inspection
Johnson & Johnson Medical (Suzhou) Ltd.Johnson & Johnson Medical (Suzhou) Ltd. – FDA Inspection, Aug 24, 2023
Record Details
This FDA Inspection record concerns Johnson & Johnson Medical (Suzhou) Ltd., with an inspection on August 24, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e70ac8f4-cccd-41e0-825f-3b313d407ba5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218179
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Johnson & Johnson Medical (Suzhou) Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 |
| April 15, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Johnson & Johnson Medical (Suzhou) Ltd.
- FDA Inspection 1244162 - 2024-06-28
- FDA Inspection 1017538 - 2017-04-20
- FDA Inspection 922761 - 2015-03-26
- FDA Inspection 861679 - 2013-11-14
- FDA Inspection 661242 - 2010-04-15
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