Company
United StatesHans Rudolph Inc, Shawnee, KS – FDA Inspections
Inspection records and compliance data for Hans Rudolph Inc in Shawnee, Kansas. 3 FDA inspections on record, 1 Form 483, last inspected February 22, 2017.
Company Profile
This profile covers Hans Rudolph Inc based in Shawnee, Kansas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected December 4, 2009. Last inspected February 22, 2017.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Records of complaint investigation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 22, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1002408 |
| October 7, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 853640 |
| December 4, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 634965 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hans Rudolph Inc
FEI Number
1922553
Address
8325 Cole Pkwy, Shawnee, Kansas 66227, United States
Country
United States
ID: d551197e-a331-416c-a659-54e657d4e479