Company
GermanySTRATEC SE, Birkenfeld, Germany – FDA Inspections
Inspection records and compliance data for STRATEC SE in Birkenfeld. 3 FDA inspections on record, 1 Form 483, last inspected April 18, 2019.
Company Profile
This profile covers STRATEC SE based in Birkenfeld, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 10, 2011. Last inspected April 18, 2019.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
- Quality Audits - defined intervals1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2019 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1087247 |
| June 6, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 840250 |
| February 10, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 712776 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
STRATEC SE
FEI Number
3003413192
Address
Gewerbestr. 37, Birkenfeld, Germany
Country
Germany
ID: 915e80d4-1029-4004-b683-1e09532124a8