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Mohammed Suhail Chowdry

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United States

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Posted By Mohammed Suhail Chowdry 31-Jul-2020 16:40
Found In Egroup: Regulatory Open Forum
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Hi, Firstly, as Ken rightly mentioned in her original post – there is no regulatory requirement for a PLD to get involved in investigations pertaining to routine manufacturing and testing. Please correct me if wrong – the only "regulatory" responsibilities for a PLD are: (a) acquiring NDC ...
Posted By Mohammed Suhail Chowdry 27-Jul-2020 11:10
Found In Egroup: Regulatory Open Forum
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Hi Ken,  Generally, Private Label Distributors (PLDs) are more concerned about investigation outcomes for product quality complaints and not necessarily all deviations, which would include - lab errors, atypical results, and OOS results that might occur during manufacturing, packaging, or testing ...