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FDA Inspection
•Blue Sky Bio, LLC•April 27, 2018

Blue Sky Bio, LLC – FDA Inspection, Apr 27, 2018

Record Details

This FDA Inspection record concerns Blue Sky Bio, LLC, with an inspection on April 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company
Blue Sky Bio, LLC
Inspection Date
April 27, 2018
Product Type
Devices
Office
Center for Devices and Radiological Health
People
  • Nicholas Z. Lu (Issuing Officer)
  • Stephen D. Eich (Company Rep)
View Company Profile

ID · a71a733c-e08e-4c3b-ad22-5b0687236a5d

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1050674
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

Other FDA inspections of Blue Sky Bio, LLC

3
DateClassificationOfficeProject area
March 10, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
December 5, 2011VAICenter for Devices and Radiological HealthCompliance: Devices
August 19, 2010NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Blue Sky Bio, LLC
  • FDA Inspection 917643 - 2015-03-10
  • FDA Inspection 756451 - 2011-12-05
  • FDA Inspection 678208 - 2010-08-19

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