Company
United StatesParker Medical Systems Division Merillville, Merrillville, IN – FDA Inspections
Inspection records and compliance data for Parker Medical Systems Division Merillville in Merrillville, Indiana. 3 FDA inspections on record, 1 Form 483, last inspected May 20, 2019.
Company Profile
This profile covers Parker Medical Systems Division Merillville based in Merrillville, Indiana, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 19, 2009. Last inspected May 20, 2019.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate process validation2 inspections
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 20, 2019 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1090202 |
| August 7, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 897907 |
| March 19, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 573525 |
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
Parker Medical Systems Division Merillville
FEI Number
1000115297
Address
1201 E 86th Pl, Merrillville, Indiana 46410, United States
Country
United States
ID: 956bf953-516d-483e-a5fe-0fe45186c57b