Company
GermanyChromsystems Instruments & Chemicals GmbH, Grafelfing, Germany – FDA Inspections
Inspection records and compliance data for Chromsystems Instruments & Chemicals GmbH in Grafelfing. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected June 23, 2016.
Company Profile
This profile covers Chromsystems Instruments & Chemicals GmbH based in Grafelfing, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected March 20, 2014. Last inspected June 23, 2016.
Most cited issue areas
- Investigation of device failures1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
- Sampling plans1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 23, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 977045 |
| March 20, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 871086 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Chromsystems Instruments & Chemicals GmbH
FEI Number
3003951180
Address
Am Haag 12, Grafelfing, Germany
Country
Germany
ID: 1205b480-038d-4b30-b2e3-822de58ec2fb