FDA Inspection
Kova Laboratories, Inc.Kova Laboratories, Inc. – FDA Inspection, Jun 26, 2014
Record Details
This FDA Inspection record concerns Kova Laboratories, Inc., with an inspection on June 26, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kova Laboratories, Inc.
- Inspection Date
- June 26, 2014
- Product Type
- Devices
View Company Profile
ID · f281f047-2b90-44d5-8d52-4e0816e90464
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883350
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kova Laboratories, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kova Laboratories, Inc.
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.