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One such way would be to leverage the agencys wide enforcement latitude by restricting imports from facilities that have never been inspected or those that refused to provide documents supporting CGMP compliance

References US Food & Drug Administration

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Brain Res Bull (1998) 45:2338.10.1016/S0361-9230(97)00417-6 50 GegelashviliGSchousboeA

Mehrhof SZ, Fleming H, Nord CL