(a) The applicant shall describe the quality assurance program (see Subpart H of this part) for the design, fabrication, assembly, testing, maintenance, repair, modification, and use of the proposed package.
(b) The applicant shall identify any specific provisions of the quality assurance program that are applicable to the particular package design under consideration, including a description of the leak testing procedures.
Title 10 published on 2013-01-01
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