FDA Inspection
KOWA CO. LTD. CHOFUKOWA CO. LTD. CHOFU – FDA Inspection, Jul 5, 2018
Record Details
This FDA Inspection record concerns KOWA CO. LTD. CHOFU, with an inspection on July 5, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · b8c95248-b92e-4c37-9bab-f0a84c84e1c8
Inspection Facts
- Inspection number
- 1058995
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(g)Design validation acceptance criteria
Full citation text and observation details available on the Dashboard.
Other FDA inspections of KOWA CO. LTD. CHOFU
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for KOWA CO. LTD. CHOFU
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.