Company
SingaporeReka Health Pte Ltd, Singapore, Singapore – FDA Inspections
Inspection records and compliance data for Reka Health Pte Ltd in Singapore. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected August 21, 2014.
Company Profile
This profile covers Reka Health Pte Ltd based in Singapore, Singapore.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected August 21, 2014.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 21, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 892666 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Reka Health Pte Ltd
FEI Number
3008687164
Address
No 2 International Business Park, The Strategy Tower One; Floor 11 Unit 01 02, Singapore, Singapore
Country
Singapore
ID: a7a13683-e491-45be-aeb5-cfdd51a4b5d5