Company
United StatesHill-Rom Inc, Batesville, IN – FDA Inspections
Inspection records and compliance data for Hill-Rom Inc in Batesville, Indiana. 9 FDA inspections on record (3 OAI), 1 Form 483, 1 warning letter, last inspected April 12, 2024.
Company Profile
This profile covers Hill-Rom Inc based in Batesville, Indiana, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 3
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected January 23, 2009. Last inspected April 12, 2024.
Most cited issue areas
- Investigation of device failures3 inspections
- Lack of Written MDR Procedures3 inspections
- Design verification - output does not meet input requirement2 inspections
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1232908 |
| November 19, 2021 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1157281 |
| November 10, 2017 | Not classified | Medical Devices & Rad Health | 1051809 |
| December 19, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 911524 |
| February 13, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 865826 |
| January 11, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 807507 |
| October 11, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 750701 |
| July 6, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 675976 |
| January 23, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 556638 |
FDA documents
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hill-Rom Inc
FEI Number
1824206
Address
1069 State Road 46 E, Batesville, Indiana 47006, United States
Country
United States
ID: 13baa578-a0c3-4149-b333-03ac13dae32b