Nycomed Failed to Investigate Temp-Related Complaints

Nycomed U.S. did not adequately investigate complaints it attributed to incorrect product storage by consumers, according to a recent Form 483. The Melville, N.Y., company’s investigation of some complaints did not address the effect of multiple filling machine breakdowns and in-process temperature excursion during the manufacturing operation, the form says. Nycomed attributed the complaints to elevated temperatures during transit.
Drug GMP Report