So, this is the big dilemma I have right now. Reading Divi's warning letter gives a clear impression that this is a long haul and does not look likely to be resolved soon. For example, how often does one hear that a company didn't have "basic" quality control. Further, there's never a single cockroach in the closet and further such issues can't be ruled out.
So, how does one find out when is the turning point (if at all) ... this is clearly a falling knife situation, isn't it?
Excerpt from the letter -
In your response, you stated that you have made several corrective actions, including updating your procedure Peak Integration Techniques for Chromatography
to include controls on the use of inhibit integration events. However,
your response is inadequate in that it did not provide specific
corrective action or supportive documentation for each drug’s
chromatographic processing parameters, including API not cited on Form
FDA 483. You have not shown how you will ensure that your test methods
are appropriate to determine whether your API conform to established
standards and specifications. Consequently, the summary data you
provided does not demonstrate that previously released lots do not
contain excessive levels of unknown impurities.
During the inspection, our investigators discovered a lack of basic
laboratory controls to prevent changes to and deletions from your firm’s
electronically-stored data in laboratories where you conduct CGMP
activities. Specifically, audit trail functionality for some systems you
used to conduct CGMP operations was enabled only the day before the
inspection, and there were no quality unit procedures in place to review
and evaluate the audit trail data.