“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
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