Company
GermanyAesku Systems GmbH & Co. KG, Wendelsheim, Germany – FDA Inspections
Inspection records and compliance data for Aesku Systems GmbH & Co. KG in Wendelsheim. 1 FDA inspection on record, 1 Form 483, last inspected April 19, 2018.
Company Profile
This profile covers Aesku Systems GmbH & Co. KG based in Wendelsheim, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected April 19, 2018.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 19, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1051217 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Aesku Systems GmbH & Co. KG
FEI Number
3007510296
Address
Mikro-Forum-Ring 3, Wendelsheim, Germany
Country
Germany
ID: 294877b0-cbd5-4836-a174-a8585c205598