FDA Inspection
Shin Chang Medical Co., Ltd.Shin Chang Medical Co., Ltd. – FDA Inspection, Apr 26, 2018
Record Details
This FDA Inspection record concerns Shin Chang Medical Co., Ltd., with an inspection on April 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 8f4080ee-3294-457c-9b1b-06c458b0d2dd
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1050218
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shin Chang Medical Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2024 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| November 17, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Shin Chang Medical Co., Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.