FDA Inspection 1327534 — FKA Distributing Co., LLC
The FDA completed an inspection of FKA Distributing Co., LLC on Sep 1, 2026 in Commerce Township, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Commerce Township, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23152 | ISO 13485:2016 Clause 7.4.3 | Impact of changes to purchased product not determined |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |