FDA Inspection
CHUNGDO PHARM. CO. LTD.CHUNGDO PHARM. CO. LTD. – FDA Inspection, Mar 7, 2013
Record Details
This FDA Inspection record concerns CHUNGDO PHARM. CO. LTD., with an inspection on March 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CHUNGDO PHARM. CO. LTD.
- Inspection Date
- March 7, 2013
- Product Type
- Devices
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ID · aa928e0a-9e30-4bb1-a457-c3bad843b772
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 825397
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CHUNGDO PHARM. CO. LTD.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| May 2, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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