FDA Inspection
Kova Laboratories, Inc.Kova Laboratories, Inc. – FDA Inspection, Jan 10, 2013
Record Details
This FDA Inspection record concerns Kova Laboratories, Inc., with an inspection on January 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kova Laboratories, Inc.
- Inspection Date
- January 10, 2013
- Product Type
- Devices
View Company Profile
ID · 596e03e9-d594-4aa2-8814-2e1036aa957e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 813609
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Kova Laboratories, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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