Particular requirement for active implantable medical devices and implantable medical devices wherever applicable The manufacturer shall record the identity of personnel performing any inspection or testing. 8.3 Control of nonconfomting product The manufacturer shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with non-conforming product shall be defined in a documented procedure. The manufacturer shall deal with non-conforming product by one or more of the following ways:— (a) by taking action to eliminate the detected non-conformity; (b) by authorizing its use, release or acceptance under concession; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India (c) by taking action to preclude its original intended use or application.