FDA Inspection
GMDASZ Manufacturing Co., Ltd.GMDASZ Manufacturing Co., Ltd. – FDA Inspection, Jan 29, 2015
Record Details
This FDA Inspection record concerns GMDASZ Manufacturing Co., Ltd., with an inspection on January 29, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 29, 2015
- Product Type
- Devices
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ID · de580d54-08f1-4531-b094-babfa6928a92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 913245
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GMDASZ Manufacturing Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2019 | Not classified | Office of Inspections and Investigations | |
| January 18, 2018 | Not classified | Office of Inspections and Investigations |
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