FDA Inspection
FKA Distributing Co., LlcFKA Distributing Co., Llc – FDA Inspection, Aug 16, 2017
Record Details
This FDA Inspection record concerns FKA Distributing Co., Llc, with an inspection on August 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c6ce4289-f237-41c5-81d3-78ea23c52645
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022695
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of FKA Distributing Co., Llc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2026 | NAI | Detroit District Office | Postmarket Assurance: Devices |
| September 22, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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