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USA Population Safety at Risk - Development of Good Laboratory Practice

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A wider survey by US FDA showed that such problems were not restricted to this one company.

Five companies were indicted for fraud following court action and the outcome for Industrial Bio-Test Laboratories was serious. The company was heavily fined, senior personnel were imprisoned and the company ceased trading.

As a result of these revelations, the US FDA developed a Code of Practice for industry. This was developed into US law - Good Laboratory Practice for Non-clinical Laboratory Studies (21 CFR Part 58) which became effective in June 1979.