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FDA Inspection
•Spectra Medical Devices, Llc•April 25, 2024

Spectra Medical Devices, Llc – FDA Inspection, Apr 25, 2024

Record Details

This FDA Inspection record concerns Spectra Medical Devices, Llc, with an inspection on April 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.

Company
Spectra Medical Devices, Llc
Inspection Date
April 25, 2024
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Nabil Nakhoul (Issuing Officer)
View Company Profile

ID · fa18cc5c-6585-4fd6-9dc1-5a515a7259ab

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1237163
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

1
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Spectra Medical Devices, Llc

2
DateClassificationOfficeProject area
March 30, 2017VAICenter for Devices and Radiological HealthCompliance: Devices
May 4, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Spectra Medical Devices, Llc
  • FDA Inspection 1007007 - 2017-03-30
  • FDA Inspection 779912 - 2012-05-04

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