Audit Inspection of cGMP Manufacturing Facility
Mock Audit for Manufacturing Facility
- Area: Massachusetts; New Hampshire
- Project Type: Auditing
About this Project
OBJECTIVE
Preparation for FDA prior-approval.
SERVICES
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.
PROJECT SUCCESS
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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