Company
TaiwanNipro Diagnostics Taiwan, Inc., Hsinchu City, Taiwan – FDA Inspections
Inspection records and compliance data for Nipro Diagnostics Taiwan, Inc. in Hsinchu City. 2 FDA inspections on record, last inspected July 21, 2016.
Company Profile
This profile covers Nipro Diagnostics Taiwan, Inc. based in Hsinchu City, Taiwan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 19, 2010. Last inspected July 21, 2016.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 21, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 989174 |
| August 19, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 680402 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Nipro Diagnostics Taiwan, Inc.
FEI Number
3002806387
Address
No.13, 1st Floor, Industry E, Road 9, Hsinchu Science Park, Hsinchu City, Taiwan
Country
Taiwan
ID: 8825d7f4-590b-4b2c-bf03-a60fc6acdebf