definiens: shall mean : failure of Final Product to meet Final SpeCifications upon receipt of Final Product by Customer ; issuance of adverse audit or inspection observatiolls from the FDA or another sjmiJar ~c, guJatory authority Telated to the Production Facility or Final Product ; · and lack of folJow - up on outstanding actjons items from'previous audits or inspections rel4tted to the Production Facility or 5 DOCSOC\717385v3\16558.0002 DL File ; J!magcI pJobal Supply AS ( ) 6.'i3.()Qjsp 141 023 11/14/2000 Tlm 17:20 FAX Final Prodoct . shan meaiJ ( j ) a significant FDA 483 observation, or its equivalent from another similar regulatory authority, likely to adversely affect the qua1ity ofF1lla ] Product, ( ii ) receipt of an FDA warning letter, or its equivale.nr, from another simjJar regulatory authority, addressing the Final Product Or key quality assurance systems ' It the Production Facility, or ( iii ) a finding by an jJ)vestigator of an absence of a key quality assurance system likely to adversely affect lhe quality of Final Product . Such inspections sha1l occur during [COMPANY] 's normal hours of operation and upon reasonable notice . [COMPANY] shan rake appropriate actions to adopt reasonable suggestions of Customer to correct .lny deficiencies identified ' by such inspection or audit . To supplement this provision, and in accordance with the frequency provi ~ ions sct for herein, Customer also may arrange, at its cOSI and expense . to have a Customer employee or other representative located on the premises of the Production Facility participate in lhe monjtoring of Final Product production . testing and packaging under this Agreement . All infonnation acquired pursuant to the provjsions of this paragraph are su ~ ject to tbe requirements of confidentiality as contained in the Confidentiality Agreement