I don't know what FDA review memorandum involves but it doesn't sound that the FDA did investigation. It could be simply that the FDA checked submitted documentation from that site and concluded this because the CRO hadn't provided any test results.
Sorry, I don't see any inconsistencies. The box clearly explains what they mean by complete lack of oversight – doing inspections many months after the trial and even then just checking the paperwork.
Sorry, I don't see any inconsistencies. The box clearly explains what they mean by complete lack of oversight – doing inspections many months after the trial and even then just checking the paperwork.