FDA Inspection
EnerconEnercon – FDA Inspection, Aug 3, 2017
Record Details
This FDA Inspection record concerns Enercon, with an inspection on August 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- James W. Whitney (Issuing Officer)
- Jason B. Prosser (Issuing Officer)
View Company Profile
ID · 2aef89a2-930b-43f0-9aa4-ef682fe12850
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020325
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 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 Enercon
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Enercon
- FDA Inspection 1204697 - 2023-04-19
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.