Regulatory deviations that need major corrective actions require huge investment in terms of resources as well as time. Instead, it is always better to be SAFE THAN SORRY.
To put it simplistically, ‘NO LOSS’ is also a big-time gain when it comes to clearing audits and inspections as well as winning clientele and consumers trust!
The intricacies of a human body are still being explored and every day we discover new facts. When a drug is added to such a complex human organ system, there are all possibilities it is bound to fetch something unknown and pivotal as each human system is unique.