FDA Inspection
Olympus Medical Products CzechOlympus Medical Products Czech – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns Olympus Medical Products Czech, with an inspection on April 12, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- April 12, 2017
- Product Type
- Medical Devices & Rad Health
- Person
- Marc S. Neubauer (Issuing Officer)
View Company Profile
ID · 0ff45312-68fc-4769-8dcd-5089d6f096b2
Inspection Facts
- Inspection number
- 1009642
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Olympus Medical Products Czech
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Olympus Medical Products Czech
- FDA Inspection 809477 - 2012-11-21
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.