Company
United StatesKapp Surgical Instrument Inc, Warrensville Heights, OH – FDA Inspections
Inspection records and compliance data for Kapp Surgical Instrument Inc in Warrensville Heights, Ohio. 3 FDA inspections on record, 1 Form 483, last inspected November 16, 2018.
Company Profile
This profile covers Kapp Surgical Instrument Inc based in Warrensville Heights, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 22, 2011. Last inspected November 16, 2018.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 16, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1071836 |
| February 24, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 915420 |
| March 22, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 716182 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Kapp Surgical Instrument Inc
FEI Number
1522875
Address
4919 Warrensville Center Rd, Warrensville Heights, Ohio 44128, United States
Country
United States
ID: 73316216-d4d7-4839-a657-d46d97b3fb46