(Total Views: 603)
Posted On: 04/15/2022 2:44:31 PM
Post# of 154119
He was essentially saying, politely, you have to get your work done.
When someone has a year to correct deficiencies, and doesn't do it, an email urging them to get it done is not a defense for not doing the work correctly. The magnitude of the deficiencies -- missing data, data not aggregated, data being put in the wrong places on the form AFTER the FDA told them the RIGHT place to put it --
No email saying "get it done" gives them an excuse for what they submitted. A GOOD company would have put everyone on it to get it finished correctly, instead of just submitting the same thing with even more errors.
When someone has a year to correct deficiencies, and doesn't do it, an email urging them to get it done is not a defense for not doing the work correctly. The magnitude of the deficiencies -- missing data, data not aggregated, data being put in the wrong places on the form AFTER the FDA told them the RIGHT place to put it --
No email saying "get it done" gives them an excuse for what they submitted. A GOOD company would have put everyone on it to get it finished correctly, instead of just submitting the same thing with even more errors.
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