A similar litany of concerns centering on the handling of complaints, deviations and recalls and their interrelationship was raised during FDA’s follow-up investigation at McNeil’s Fort Washington facility completed in mid-December as was found in the follow-up at its Las Piedras, Puerto Rico plant that ended a few weeks earlier (IPQ “In the News” December 7, 2010).
Both were extended inspections resulting in lengthy 483s. FDA was on site for 25 days during the Fort Washington inspection, which began in late October. The six-week Las Piedras inspection, which ended in early November, included 19 days of FDA on-site presence.
The two investigations delved further into McNeil’s handling of high-profile recalls conducted in 2009 and earlier in 2010 and issues raised during FDA inspections of the facilities in that time frame. The McNeil compliance problems prompted Congressional inquiry in mid-2010 (IPQ “In the News” June 2).
FDA’s previous inspection at Fort Washington was in April 2010. A recall of about 1,500 lots of liquid infant’s and children’s Tylenol, Motrin, Zyrtec and Benadryl, and a voluntarily shut down of the plant were announced at the close of the two-week inspection (IPQ “In the News” May 6, 2010).
As in the recently-completed inspection, among the FDA concerns raised in April was McNeil’s failure to adequately investigate and take action on complaints/deviations.
The Las Piedras November 483 also included repeat observations from the previous January 2010 inspection, which resulted in a warning letter. The recurrent issues involved execution of its recall procedures and cleaning/maintenance.
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