FDA Inspection
Henan Kangdi Medical Devices Co. LtdHenan Kangdi Medical Devices Co. Ltd – FDA Inspection, Mar 7, 2019
Record Details
This FDA Inspection record concerns Henan Kangdi Medical Devices Co. Ltd, with an inspection on March 7, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3ddf2003-ec69-4e13-b0a6-12ff64e9eacc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1084134
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
Other FDA inspections of Henan Kangdi Medical Devices Co. Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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