FDA Concern with McNeil’s Complaint Handling Extends to Lancaster, PA Facility

McNeil’s complaint handling – a problem area cited in FDA’s January warning letter to parent company J&J regarding its Las Piedras, Puerto Rico plant and in an April inspection at the OTC drug manufacturer’s  Fort Washington facility (IPQ “In the News,” May 6, 2010) – was also of concern to agency investigators in an inspection completed July 9 at McNeil’s plant in Lancaster, PA.

FDA’s two-week inspection at the Lancaster, PA plant, jointly owned by Merck as indicated on the 483, was conducted by Sharon Thoma, who also inspected McNeil’s Fort Washington plant in April, and Anita Michael.  The products manufactured at the plant include Imodium Plus caplets, Pepcid Complete chewable tablets, and Mylanta.

The 12-page FDA form 483 issued following the inspection contains twelve observations covering four quality systems:  quality (5), laboratory (4), production (1), and facilities and equipment (2).

Among the quality system problems cited was a failure to “thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.”  When discrepancies were reviewed, the 483 asserts, the reports did not always include appropriate conclusions and follow-up.  One example referenced was a lack of follow-up concerning “multiple and repeated product mix-up complaint investigations to determine the causes for the repeated mix-up of tablets.”  FDA noted that the investigation was incomplete as the firm did not review repeated previous complaints observed for the same product line and a similar mix-up of tablets.

Similar observations regarding McNeil’s handling of complaints were cited in the January warning letter and the April 483 issued at Fort Washington (the July Lancaster 483 did not reference the earlier citations).

[More on FDA’s findings at the Lancaster facility and comparison with the findings at the other McNeil facilities is provided for subscribers here.  Included are links to the two 483s and warning letter.]