Inspection Readiness & Enforcement






*"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?."*

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

Compliance Architects^®: Innovative, business-focused compliance for FDA-regulated industry.