FDA Inspection
Reka Health Pte LtdReka Health Pte Ltd – FDA Inspection, Aug 21, 2014
Record Details
This FDA Inspection record concerns Reka Health Pte Ltd, with an inspection on August 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Reka Health Pte Ltd
- Inspection Date
- August 21, 2014
- Product Type
- Devices
View Company Profile
ID · 93c7b654-2264-4248-bba1-bea9cafb5820
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 892666
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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