2, Testing into compliance (in other words read: you keep on testing till you get a positive result
3, Not saving electronic or hard copy data that would confirm the failing results (which in a sense implies fabrication)
4, Disabled audit trail feature.
5, Inadequate out of specification investigation.
6, Inadequate CAPAs (Corrective and Preventive Action).
7, Root cause lacking scientific evidence.
1, section 211.22(d): The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed;
2, section 211.160 (b): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures.
1, immature quality culture.
2, Investigation focused on giving any explanation that may work, and not on what caused the problem in order to prevent recurrence and predict outcome.
Others felt these need to be perhaps seen as a warning letters issued based on the conclusions that these might have happened and that it is now for the companies to prove that it has not happened. While some others felt, these are concerns which may not necessarily mean all have them. All were however agreed that these are the expectations of the regulator and companies have no option but to satisfy them and therefore move in the direction of what is expected. Also, some felt it also goes to show that it is not as if US companies are doing any better because the points listed out are for all the warning letters issued by the US regulator.
But that is not to say, it is the only reason. As the presentation pointed out, the big worry is that the cases of non-adherence to some of the quality norms have also increased. There are some recurring citations and there are newer challenges too that need to be kept in mind.