Audit Inspection of cGMP Manufacturing Facility

Mock Audit for Manufacturing Facility
  • Area: Massachusetts; New Hampshire
  • Project Type: Auditing

About this Project


Preparation for FDA prior-approval.


PSC® performed mock FDA prior approval audit. Performed inspection of cGMP Manufacturing facility and the associated cGMP Quality Systems. PSC® developed audit response plans, corrective action and regulatory compliance plan, and trained staff. PSC®, developed cGMP training content for facilities.


The mock audit led to a successful FDA prior approval audit. The company is also still a client of ours to this day.

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