Novartis has received another significant 483 at its Lincoln, Nebraska plant – the second one in less than six months – citing repeat observations from the July, 2011 inspection, centering around complaint handling and investigation. The 23-page 483 issued to the firm at the end of a 21-day inspection contains ten observations, seven of which are cited as repeat observations from the July inspection.
The 13-page July 483 focused primarily on complaint handling and investigation related to a recall of OTC products six months earlier (IPQ “In the News” January 14, 2012). The first observation on the January inspection is a repeat observation related to the lack of quality unit oversight in the manufacture of OTC products, citing inadequacies that appear in the other repeat observations as evidence of quality unit failure.
The other repeat observations from the previous inspection involve inadequacies with: ● investigation of “critical and major” complaints ● investigations of problems with OTC products not extending to other batches ● investigations of product mix-ups ● filing of 3-day field alerts ● quality personnel staffing levels, and ● sufficiency and frequency of GMP training.
Among the observations that were not specifically noted to be repeats from the previous inspections were two related to the dominant theme of complaint handling – the annual review of complaint and recall trends and failure to follow complaint procedures. Equipment cleaning was also raised as a concern in the most recent inspection.