Regulatory History
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.
- June 2009, General Inspection
- March/April 2010, General and PAI
- June 2011 General Inspection
- November 2012, General Inspection and PAI
- July 2013, PAI
- May 2014, General Inspection and 3 PAI’s
- April 2015, General Inspection
- October 2015, 3 PAI’s
- May 2016, 2 PAI, 1 post approval
EU Inspection
- February 2015 – GMP certificate issued
