“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?”
- 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