FDA Inspection
Monarch Medical Eq LtdMonarch Medical Eq Ltd – FDA Inspection, Oct 9, 2015
Record Details
This FDA Inspection record concerns Monarch Medical Eq Ltd, with an inspection on October 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Monarch Medical Eq Ltd
- Inspection Date
- October 9, 2015
- Product Type
- Devices
View Company Profile
ID · 267563eb-c6a2-493a-8742-4b711e00a35e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945614
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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