Company
United StatesNidek Medical Products Inc, Birmingham, AL – FDA Inspections
Inspection records and compliance data for Nidek Medical Products Inc in Birmingham, Alabama. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected October 19, 2017.
Company Profile
This profile covers Nidek Medical Products Inc based in Birmingham, Alabama, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 24, 2010. Last inspected October 19, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures2 inspections
- Lack of or inadequate DHR procedures2 inspections
- Complete files maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 19, 2017 | Not classified | Medical Devices & Rad Health | 1042510 |
| August 16, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 985390 |
| November 20, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 855858 |
| April 10, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 775100 |
| February 24, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 650979 |
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
Nidek Medical Products Inc
FEI Number
1039215
Address
3949 Valley East Industrial Dr, Birmingham, Alabama 35217, United States
Country
United States
ID: 8fe620e0-7ed2-450b-87e1-8aebea515bd8