definiens: means a three - day NADA / ANA DA field alert report described in 21 C.F.R. 514.80 ( b)(1 ) that indicates the potential o f a quality issue ( e.g. bacterial contamination, significant chemical, physical degradation, adulter ated or misbranded product ) . As applicable, Manufacturer shall promptly send any reports relati ng to such inspections, Recalls or violations or potential violations of Law to Customer, provided t hat Manufacturer may reasonably redact any such reports to protect its confidential informatio n ( including information regarding products not sold to or systems not used to manufacture Products for the other Party ) . In the event that any such Governmental Authority requests, but does not seize, a sample of the Product in connection with any such inspection, Manufacturer, as the case may be ( i ) shall promptly notify Customer of such request, ( ii ) if permitted by law, shall satisfy su ch request only after receiving Customer ’s approval, such approval not to be unreasonably with held or delayed, ( iii ) shall follow any reasonable procedures instructed by Customer in res ponding to such request and ( iv ) shall promptly send a sample of any Product requested by the Governmental Authority to Customer