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FDA Inspection
•FH INDUSTRIE•July 23, 2015

FH INDUSTRIE – FDA Inspection, Jul 23, 2015

Record Details

This FDA Inspection record concerns FH INDUSTRIE, with an inspection on July 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
FH INDUSTRIE
Inspection Date
July 23, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · b2a2c57d-8654-4573-b795-6631ef877601

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
940386
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

3
  1. 21 CFR 806.10(a)(1)Report of risk to health
  2. 21 CFR 803.50(a)(2)Individual Report of Malfunction
  3. 21 CFR 820.25(a)Personnel

Full citation text and observation details available on the Dashboard.

Other FDA inspections of FH INDUSTRIE

2
DateClassificationOfficeProject area
May 19, 2025Not classifiedOffice of Inspections and Investigations
September 6, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for FH INDUSTRIE
  • FDA Inspection 1273707 - 2025-05-19
  • FDA Inspection 1064620 - 2018-09-06

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