Compliance Readiness Initiatives

• Create/Update QMS for conformance with current applicable regulations and standards
• Create full complaint handling, nonconformance, or CAPA handling systems to roll out to your company
• Train all personnel in your company or department what to do when an FDA investigator walks in the front door
• Create processes for front room and back room operations during FDA inspections

Neozene, as your Compliance Readiness partner can help you answer the following questions:

1. Who can talk to the FDA investigator?
2. The FDA investigator asked for my internal audit reports, do I have to show it to them?
3. What do I do when an FDA investigator wants to take pictures of my manufacturing area?
4. Can I record the FDA interviews in order to review them later?