FDA Inspection
CHUNGDO PHARM. CO. LTD.CHUNGDO PHARM. CO. LTD. – FDA Inspection, Jan 8, 2026
Record Details
This FDA Inspection record concerns CHUNGDO PHARM. CO. LTD., with an inspection on January 8, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- CHUNGDO PHARM. CO. LTD.
- Inspection Date
- January 8, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 3d89df6a-4f09-4d7c-b859-21c9c6bac267
Inspection Facts
- Inspection number
- 1299018
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, 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 CHUNGDO PHARM. CO. LTD.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 7, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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