Regulatory History – Whippany

Regulatory History – Whippany2018-07-21T09:55:56+00:00

FDA Inspections

Since Halo Pharma was founded in 2009, the following inspections have been completed. Over the past eight years, all PAI’s and general inspections of our Whippany, NJ facility resulted in favorable inspections including “recommended for approval” status of every submission as well as “compliant status” for each general inspection.

  • May 2018, General Inspection and 1 Pre-Approval, Compliant and Recommended for Approval
  • August 2017, PAI, Recommended Approval
  • March 2017, General Inspection, Compliant
  • May 2016, 2 Pre-Approval and 1 Post Approval, Compliant

EU Inspection

  • January 2017, MHRA General Inspection, Compliant
  • February 2015 – GMP certificate issued