Published March 14, 2011 in Washington Drug Letter
The FDA has said enough is enough to McNeil Consumer Healthcare over its repeated manufacturing problems, issuing a consent decree Thursday that indefinitely closes one plant and places oversight over two others.
The agency said the Johnson & Johnson (J&J) subsidiary, which has been plagued with recalls of its OTC drugs relating to current good manufacturing practices (cGMP) violations, will not be able to reopen its troubled Fort Washington, Pa., plant until a litany of changes have been made.
The decree, filed in a Pennsylvania federal court, places strict timeframes McNeil must meet or face fines, further recalls and additional shutdowns. Its also names as defendants McNeil’s vice president of quality, Veronica Cruz, and Hakan Erdemir, the company’s vice president of operations, for violating federal law by distributing adulterated drugs.
Within 30 days, McNeil needs to outline its plans to destroy all lots of drugs in its possession or recalled since December 2009 that were made at its Fort Washington, Lancaster, Pa. and Las Piedras, Puerto Rico, facilities.
The FDA also ordered McNeil to cease production at Fort Washington until it completes a lengthy 10-step remediation process. The remediation plan spans seven of the order’s 26 pages. The company previously said it hoped to reopen the plant mid-year after it closed in April 2010, a timetable that now looks all but impossible.
Covers Three Plants
McNeil said that it expects the consent decree to govern the company’s operation of the three plants for at least five years following the completion of the remediation plan. In July, the company said it was developing its own plan, which included making significant investment in manufacturing facilities, reorganizing operations and developing a comprehensive program to ensure sustainable compliance with regulatory and its own quality requirements (WDL, July 26, 2010).
The decree’s remediation plan includes hiring an independent cGMP consultant for each facility. The consultant must certify the plant’s equipment and manufacturing processes are compliant before the FDA inspects the facility.
McNeil must also outline a quality control plan and employee training programs to ensure GMP knowledge and processes.
Although facilities in Lancaster and Puerto Rico can remain open, they must also hire independent consultants and begin a comprehensive cGMP implementation plan or else face closure.
If McNeil violates the decree, the FDA may order the company to cease production in Lancaster and Las Piedras and recall products. The agency could also levy fines of $15,000 a day and an additional $15,000 for each violation of the law up to $10 million a year.
Recalls have hammered McNeil’s facilities in the past year. J&J has previously said the recalls cost the company $900 million in sales last year (WDL, Jan. 31).
As one recent example, the company in January recalled nearly 43 million bottles of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol upper respiratory products, Benadryl, Sudafed PE and Sinutab that were made at the Fort Washington plant before it closed (WDL, Jan. 24).
The FDA issued McNeil a warning letter Jan. 15 for being too slow to alert the FDA and consumers to trace amounts of a wood-treating chemical in some of its products, including its OTC drug Tylenol.
To view a copy of the consent decree, visit www.fdanews.com/ext/files/Certified_Filed_Consent_Decree_USA_v._McNeil_PPC.pdf. — David Pittman