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Apicore, LLC.
GMP Inspections
  1. FDA inspected the manufacturing facility in Somerset, NJ for the first time in September '06 as a Prior Approval Inspection triggered by one of our customer's ANDAs.
  • The second FDA inspection took place in December 2008. 
  1. A third inspection was conducted in July 2010. No form FDA483 was issued at the conclusion of the inspection.