FDA Inspection
Dreve Otoplastik GmbhDreve Otoplastik Gmbh – FDA Inspection, Aug 21, 2014
Record Details
This FDA Inspection record concerns Dreve Otoplastik Gmbh, with an inspection on August 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dreve Otoplastik Gmbh
- Inspection Date
- August 21, 2014
- Product Type
- Devices
View Company Profile
ID · 00cfeefc-49e0-4a89-879a-ae1a0f6d122d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 894893
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40(b)Document changes, review and approval, communication
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dreve Otoplastik Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dreve Otoplastik Gmbh
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.