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FDA Inspection
•VapoCoolShot, Inc.•October 26, 2023

VapoCoolShot, Inc. – FDA Inspection, Oct 26, 2023

Record Details

This FDA Inspection record concerns VapoCoolShot, Inc., with an inspection on October 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company
VapoCoolShot, Inc.
Inspection Date
October 26, 2023
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Gisselle I. Sensebe (Issuing Officer)
View Company Profile

ID · 3eb1eea4-20ee-457f-8eae-5bb54da3ac3c

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1221606
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.20(c)Management review dates
  2. 21 CFR 820.22Quality Audits - defined intervals
  3. 21 CFR 820.25(b)Training records

Full citation text and observation details available on the Dashboard.

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