Company
Korea (the Republic of)Bistos Co Ltd, Seongnam, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Bistos Co Ltd in Seongnam. 2 FDA inspections on record, last inspected November 07, 2019.
Company Profile
This profile covers Bistos Co Ltd based in Seongnam, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 27, 2012. Last inspected November 7, 2019.
Most cited issue areas
- Design verification - Lack of or inadequate procedures1 inspection
- Documentation1 inspection
- Documentation of software validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1113055 |
| September 27, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 804127 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bistos Co Ltd
FEI Number
3006179052
Address
104~109 & 116~122ho, Jungang Induspia 3, 27, Sagimakgol-ro 105beon-gil, Jungwon, Seongnam, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 9f1d8538-bcae-4345-83aa-1e816266645c