FDA Inspection
FKA Distributing Co., LlcFKA Distributing Co., Llc – FDA Inspection, Sep 22, 2009
Record Details
This FDA Inspection record concerns FKA Distributing Co., Llc, with an inspection on September 22, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- FKA Distributing Co., Llc
- Inspection Date
- September 22, 2009
- Product Type
- Devices
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ID · f746d8c0-46b7-48a3-9b94-b1a12053b048
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613978
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.50Purchasing controls, 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 |
| August 16, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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