Day

August 28, 1997
28
Aug

Connaught Laboratories Ltd.

August 28, 1997
11. Failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)] in that there are no procedures for control of the software including procedures to control inappropriate or incorrect changes to the specifications...
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