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1263061

Harmonic Energetic Technologies Inc. — FEI 3005196642

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 7, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Liverpool, NY (United States)

Facility

Other inspections at this facility

  • 1286366 (NAI Wed Oct 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1174257 (NAI Wed Jun 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114454 (VAI Tue Jan 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
2280021 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
237121 CFR 820.30(a)Design control - no procedures
337521 CFR 820.198(e)Records of complaint investigation
407021 CFR 820.30(g)Design validation - documentation