FDA Inspection
Aesku Group GmbH & Co. KGAesku Group GmbH & Co. KG – FDA Inspection, Mar 2, 2017
Record Details
This FDA Inspection record concerns Aesku Group GmbH & Co. KG, with an inspection on March 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 71e9b782-ad62-4efe-8a8b-ecb07b979329
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008028
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aesku Group GmbH & Co. KG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Aesku Group GmbH & Co. KG
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.