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FDA Inspection
•Perouse Medical•December 11, 2014

Perouse Medical – FDA Inspection, Dec 11, 2014

Record Details

This FDA Inspection record concerns Perouse Medical, with an inspection on December 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company
Perouse Medical
Inspection Date
December 11, 2014
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 722cbd96-dcaf-4c98-b3cc-67ebe46f28ea

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
906580
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

2
  1. 21 CFR 806.10(b)Time to report - 10 days
  2. 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Perouse Medical

1
DateClassificationOfficeProject area
November 21, 2013OAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Perouse Medical
  • FDA Inspection 857492 - 2013-11-21

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