Company
GermanyBit Analytical Instruments Gmbh, Schwalbach Am Taunus, Germany – FDA Inspections
Inspection records and compliance data for Bit Analytical Instruments Gmbh in Schwalbach Am Taunus. 2 FDA inspections on record, 1 Form 483, last inspected November 17, 2016.
Company Profile
This profile covers Bit Analytical Instruments Gmbh based in Schwalbach Am Taunus, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 3, 2010. Last inspected November 17, 2016.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2016 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 993919 |
| June 3, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 669147 |
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
Bit Analytical Instruments Gmbh
FEI Number
3003601075
Address
Am Kronberger Hang 3, Schwalbach Am Taunus, Germany
Country
Germany
ID: 270b1d6f-6d58-4cc3-8c96-2503a416dcbe