definiens: For ~urposes of this Exhibit D, shall be defined aseny major gap in th(~ q~~lity system that may impact final product quality and/or .. a repeat observation from a previous aUd~ All Unacceptable observations mus~ rectified prior to the start of irlitial production runs of the produ§f A corrective action plan for all Unacceptable deficiencies must~~ presented to [COMPANY] within 30 ~ys of the audit and must be rectified within 60 days ' of the aud§ Maintaining a qualified status requires an annual audit with&ero ~1!7observations and agreed upon improvement levels in customer satisfaction metrics . Qualified status will be negated if the audit revealslri .. ~observation and a corrective action plan is not receiv ~ on within@O day ~ nd corrective action does not take place withingo dayj Acceptable Product Design Control : [COMPANY] will be expected to adhere to the design control requirements as detailed ineSR 21 CFR § 820 -.30 ( A)-("1 32 CONFIDENTIAL TREATMENT REQUESTED Acceptable ProductIPkg . Stability : As part of the development of the Product, [COMPANY] will be expected to demonstrate, through supportin.ij the data, ffijstification for the shelf life to be affixed to the Produ < ! Sterile Products and packaging must adhere to the appropriate standards of the tAssociation for the Advancement of Medical Instrumentation ij or [ he Intemational Organization for Standardization ( -"ISO ) fOrE, terility, validatioj and@icrobial testi~