Company
United StatesBaptist Health Hardin, Elizabethtown, KY – FDA Inspections
Inspection records and compliance data for Baptist Health Hardin in Elizabethtown, Kentucky. 8 FDA inspections on record, last inspected October 29, 2021.
Company Profile
This profile covers Baptist Health Hardin based in Elizabethtown, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 3
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected February 12, 2010. Last inspected October 29, 2021.
Most cited issue areas
- Establish, maintain and follow manufacturing SOPs2 inspections
- Adverse reaction - fatality1 inspection
- Adverse Reaction - Investigations1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 29, 2021 | NAI | Biologics · Vaccines and Allergenic Products | 1156222 |
| May 1, 2018 | NAI | Biologics · Blood and Blood Products | 1050606 |
| January 13, 2016 | NAI | Biologics · Blood and Blood Products | 956230 |
| March 3, 2015 | VAI | Biologics · Blood and Blood Products | 917307 |
| January 15, 2013 | NAI | Biologics · Blood and Blood Products | 814343 |
| December 13, 2012 | VAI | Biologics · Blood and Blood Products | 810741 |
| February 8, 2011 | VAI | Biologics · Blood and Blood Products | 709579 |
| February 12, 2010 | NAI | Biologics · Blood and Blood Products | 646619 |
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
Baptist Health Hardin
FEI Number
1070396
Address
913 N Dixie Ave, Elizabethtown, Kentucky 42701, United States
Country
United States
ID: f4fd7f80-6b5d-40db-9c56-1863941c5298