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FDA Inspection
•Lake Region Manufacturing, Inc•February 17, 2009

Lake Region Manufacturing, Inc – FDA Inspection, Feb 17, 2009

Record Details

This FDA Inspection record concerns Lake Region Manufacturing, Inc, with an inspection on February 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company
Lake Region Manufacturing, Inc
Inspection Date
February 17, 2009
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 7fae2f82-06bd-46cb-bf31-a43487f93ded

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
563965
FDA center
Medical Devices & Rad Health
Project area
Bioresearch Monitoring

FDA Citations

1
  1. 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Lake Region Manufacturing, Inc

3
DateClassificationOfficeProject area
June 2, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
September 11, 2014NAICenter for Devices and Radiological HealthCompliance: Devices
October 17, 2011NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Lake Region Manufacturing, Inc
  • FDA Inspection 977543 - 2016-06-02
  • FDA Inspection 896527 - 2014-09-11
  • FDA Inspection 752481 - 2011-10-17

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