J&J cited by FDA for another manufacturing facility
pharmafile | July 20, 2010 | News story | Manufacturing and Production |Â Â J&J, JJ, manufacturing complianceÂ
Another week, another raft of bad news for Johnson & Johnson’s manufacturing division. With one production facility already shut down because of quality control problems the company is now facing scrutiny of another.
The US Food and Drug Administration (FDA) has issued a ‘Form 483’ report to J&J over conditions at the plant in Lancaster, Pennsylvania, after an inspection uncovered deviations from Good Manufacturing Practice (GMP).
In May, J&J shut down manufacturing at another Pennsylvanian facility – operated by subsidiary McNeil Consumer Healthcare at Fort Washington – in the wake of a catalogue of quality issues including contamination with bacteria and particulate matter. Those problems led to the recall of 135 million bottles of paediatric medicines, including flagship product Tylenol.
Lancaster is the fourth facility in the J&J group to be cited by the FDA this year, raising concerns that the manufacturing issues may indicate a systemic compliance problem across the group.
In January J&J received a warning letter from the FDA about a plant in Puerto Rico, while in March a plant in Irvine, California operated by the company’s Ethicon medical device subsidiary, was also pulled up for GMP transgressions.
The latest Form 483 will not help J&J’s battered reputation. The company is already being examined by a Congressional committee and the FDA’s Office of Criminal Investigations over its manufacturing problems and last week said it would cut 300 jobs at the Fort Washington plant, some 75% of the total workforce, as it is likely to remain closed until the middle of next year.
Details of the transgressions at Lancaster have not been released yet as commercially-sensitive information has not yet been blanked out of the letter. Only after this has been done will the letter be made available publicly on the agency’s website.
The Lancaster facility, like Fort Washington – is part of J&J’s consumer health operation. It is operated by Johnson & Johnson-Merck Consumer Pharmaceuticals, a joint venture J&J and Merck & Co set up at the end of the 1990s to develop and market over-the-counter drugs derived from Merck’s prescription medicines.
Products made at the facility include the antacid Mylanta, Pepcid (famotidine) for heartburn and the anti-diarrhoeal Imodium (loperamide).
“Johnson & Johnson/Merck Consumer Pharmaceuticals takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible,” said the companies in a statement.
“We will provide a detailed response to the FDA and work diligently to address all observations.”
Phil Taylor
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