FDA Inspection
Fudakang Industrial Co LtdFudakang Industrial Co Ltd – FDA Inspection, Mar 12, 2026
Record Details
This FDA Inspection record concerns Fudakang Industrial Co Ltd, with an inspection on March 12, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Fudakang Industrial Co Ltd
- Inspection Date
- March 12, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · b820d956-fd70-4926-9601-ba3201988f39
Inspection Facts
- Inspection number
- 1311204
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
- ISO 13485:2016 Clause 4.1.4Changes to the QMS not adequately controlled or evaluated
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Other FDA inspections of Fudakang Industrial Co Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2017 | Not classified | Office of Inspections and Investigations | |
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Fudakang Industrial Co Ltd
- FDA Inspection 1223751 - 2023-10-19
- FDA Inspection 1007166 - 2017-03-17
- FDA Inspection 890431 - 2014-08-07
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