Company
United StatesFKA Distributing Co., Llc, Commerce Township, MI – FDA Inspections
Inspection records and compliance data for FKA Distributing Co., Llc in Commerce Township, Michigan. 3 FDA inspections on record, 2 Form 483s, last inspected September 01, 2026.
Company Profile
This profile covers FKA Distributing Co., Llc based in Commerce Township, Michigan, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 22, 2009. Last inspected September 1, 2026.
Most cited issue areas
- Complaint handling records not maintained1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- GUDID Information required for unique device identification.1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 1, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1327534 |
| August 16, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1022695 |
| September 22, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 613978 |
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
FKA Distributing Co., Llc
FEI Number
1832894
Address
3000 N Pontiac Trl, Commerce Township, Michigan 48390, United States
Country
United States
ID: 056ed4e5-d24a-44f8-a8af-6fc556855e24