FDA Inspection
Medexel Co., Ltd.Medexel Co., Ltd. – FDA Inspection, May 26, 2016
Record Details
This FDA Inspection record concerns Medexel Co., Ltd., with an inspection on May 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medexel Co., Ltd.
- Inspection Date
- May 26, 2016
- Product Type
- Devices
View Company Profile
ID · f4b72aaa-15c6-4b15-8c3f-75c556d36540
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 973067
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Medexel Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
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