Inspection Readiness and Enforcement Services

We are expecting an FDA inspection, and we’re not sure that we’re ready.”

“We just received a 483 and don’t have the experience or resources to fix the problems.”

“We thought our 483 response was perfect — now we’ve got a Warning Letter — what should we do differently, and what are the risks if the FDA doesn’t accept our response?”

Compliance Architects® provides the following expert advisory and consulting services:

FDA Inspection Readiness

  • Mock Inspections
  • Inspection Preparation Training
  • Facility preparation / housekeeping review
  • HACCP Quality Plans
  • Risk management plans
  • Issue review and summary documentation development
  • Pre-approval inspections
  • Product safety reviews & response summaries

Audits & Assessments

  • Mock FDA Inspections
  • Compliance / Quality Assessments
  • Compliance / Quality Audits
  • Supplier audits and assessments
  • Quality and compliance staff assessments

FDA Enforcement Response / Remediation

  • FDA-483 and Warning Letter Response Advice & Development
  • Consent Decree Remediation / Prevention
  • Recall criticality assistance, response advice and plan development
  • Remediation program management & execution
  • Import Detention Resolution
  • Crisis Management / Communications