McNeil’s Compliance Problems Continue With New FDA Inspection Findings and a Recall

Compliance problems continued to plague J&J’s OTC drug subsidiary McNeil in November with the firm announcing the recall of another bolus of children’s medicines made at its Fort Washington plant and the receipt of a substantial 483 from FDA investigators at the conclusion of a lengthy inspection of its Las Piedras, Puerto Rico facility.

Noteworthy in the recently-completed inspection and report are:  insights into McNeil’s so-called “phantom recall” from last year – most recently referred to by Congress as a “silent recall” (IPQ “In the News” November 14)deficiencies that occurred both before and after J&J submitted a “comprehensive action plan” (CAP) to FDA in July and hired a third-party consultant (IPQ “In the News” June 2) issues found with the firm’s deviation/OOS investigations even after review/approval by the third party consultant, and two observations, highlighted as “recurrent,” involving the responsibilities of the quality unit and cleaning and maintenance procedures.

FDA’s most recent foray into GMP compliance at the Puerto Rico facility followed in the wake of a series of adverse inspections and a warning letter received by the firm in January, and a Congressional inquiry into McNeil’s compliance and recall problems across its Las Piedras and Fort Washington, Pennsylvania facilities which began in May.

The January warning letter cited concerns with corrective and preventive action (CAPA) for customer complaints. It was issued soon after a recall initiated by McNeil in December 2009 and expanded in January of Tylenol Arthritis Pain Caplets after consumer complaints of a foul odor and “temporary and non-serious gastrointestinal events.” (IPQ “In the News May” 6).

At the subsequent Congressional hearing held in May, J&J announced that McNeil and its outside consultants were in the process of developing a comprehensive action plan on quality improvements, which the company subsequently shared with FDA and implemented in July.

[Analysis of the context and significance of the November McNeil 483 and recall is provided for subscribers here.  Non-subscribers may purchase this story for $75 by contacting Karen Bertani,  For IPQ subscription information, click here.]