FDA PAI Assistance
The culmination of years of work and perseverance come to head during your FDA Pre-Approval Inspection (PAI). The PAI is like a final exam for your company, employees, facility and soon-to-be commercial process. Kymanox has experience in some key PAI areas that could be the difference between a verbal comment, a 483 Observation or a Warning Letter. Consider supplementing your Regulatory/QA audit team with a consultant that has been through four successful PAI's in various Manufacturing Sciences and Process Engineering roles. Some areas of expertise are:
- Equipment, Facility and Utility Validation
- Process Equipment Performance Qualifications
- Defending Technical Assessments on Product
- Retrospective Analysis and Risk Assessments
- Technical Analysis of Batch Record Data
- Data Integrity
- Corrective and Preventive Actions (CAPA)
Immediately following your PAI, your action item list may be beyond the capabilities of your current staffing levels. Supplement your staff to help prioritize and work through the list of observations. The written responses to any 483's or Warning Letters are as important as what you do to correct them. In some cases, a second and organized presentation of the facts puts a 483 Observation to rest, saving you considerable time and money.