Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-157

Just a few random observations from someone who has endured many FDA inspections over the years:

• the fact that an inspection has been scheduled is a positive, it would indicate that there are no major red flags in the resubmission
• having said that, the FDA would need to schedule anyway if they are to meet their target dates
• AFAIK, the Tuas cell facility has not been inspected by FDA (at least, it is not an FDA approved facility) - the inspections referred to are the adjacent mammalian monoclonal facility - the facility MSB uses is completely separate except for some shared services
• snap inspections are uncommon - indeed regulatory agencies around the world have been criticised for notifying companies well in advance of inspections - I would be certain that MSB has been told the dates as that is my experience
• preparation is key, and it looks like MSB and Lonza have done a good job here, but FDA has the uncanny ability to catch you out on minor infringements. I've had the unpleasant experience of the inspector focussing on a totally unexpected area of the operation to the exclusion of the major components, just because that was his area of expertise.
• any history of Lonza Walkersville is essentially irrelevant - it is an old tired plant compared to Singapore
• Lonza is a professional operation with loads of experience in inspections by FDA and other regulatory agencies, so we should have a lot of confidence in a successful outcome
• however, be prepared for a CRL which looks terrible but which is quite often par for the course - on a first inspection a CRL is almost inevitable, but any deficiencies are usually easily addressed - don't be panicked if we get one!