Company
United StatesCentre Light Solutions, LLC, Mishawaka, IN – FDA Inspections
Inspection records and compliance data for Centre Light Solutions, LLC in Mishawaka, Indiana. 1 FDA inspection on record, 1 Form 483, last inspected May 30, 2018.
Company Profile
This profile covers Centre Light Solutions, LLC based in Mishawaka, Indiana, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected May 30, 2018.
Most cited issue areas
- Design validation - user needs and intended uses1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures for labeling1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 30, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1054686 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Centre Light Solutions, LLC
FEI Number
3012545118
Address
3102 N Home St, Mishawaka, Indiana 46545, United States
Country
United States
ID: d19f9191-5337-4ae9-ba07-4863d8e5372e