Supported Client’s FDA Inspection And Post-Inspection Response

Posted by Bob Duffy on June 5, 2017 in Regulatory & Standards Compliance Projects

FDA, Inspection, QMS

Challenge

Client needed support during FDA Inspection and implementing post-inspection response.

Actions

• Helped organize QMS documents and prepare Client staff prior to inspection.
• Supported Client staff throughout FDA Inspection.
• Helped plan and execute corrective and preventive actions to respond to inspection observations.
• Helped prepare written response to inspection observations.

Results

Client completed FDA Inspection, subsequent corrective and preventive actions and written response.