FDA Inspection
Arrow Medical LimitedArrow Medical Limited – FDA Inspection, Oct 31, 2019
Record Details
This FDA Inspection record concerns Arrow Medical Limited, with an inspection on October 31, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arrow Medical Limited
- Inspection Date
- October 31, 2019
- Product Type
- Devices
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ID · e7244698-40b7-4f5e-8cf3-d6664788a3cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109983
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 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 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Arrow Medical Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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