Actually, the FDA reviews the validation of the manufacturing processes. According to 21 CFR 820.75, which states that “where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated”. The validation for manufacturing processes should be documented according to the respective procedures established.
Some companies don’t do a lot of validating because they don’t have the resources or even the necessary understanding. Validation process cost a lot, but validation always required if your company making a new device.(its not a choice).SO Validation process is the right thing to do, because if your product failed to deliver the user needs, it can cause devastating personal consequences, even death. So, validation helps minimize the risks and ensure you’re manufacturing devices according to the user needs.