FDA Inspection
FKA Distributing Co., LlcFKA Distributing Co., Llc – FDA Inspection, Sep 1, 2026
Record Details
This FDA Inspection record concerns FKA Distributing Co., Llc, with an inspection on September 1, 2026, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- FKA Distributing Co., Llc
- Inspection Date
- September 1, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 811b0d9a-5b78-474a-bfaa-1bac1916bb26
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1327534
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 7.4.3Impact of changes to purchased product not determined
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
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Other FDA inspections of FKA Distributing Co., Llc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 22, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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