Embattled Johnson & Johnson (NYSE: JNJ), already under intense scrutiny over conditions at a Pennsylvania plant that makes children's pain and cold drugs, is now being cited for problems at another one of its plants, CNNMoney is reporting. It marks the latest problem for the beleaguered drug giant, which earlier this month announced it was recalling 21 lots of OTC medicines sold in the U.S., Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago and Jamaica. The FDA confirmed the issuance of the Form 483 in an emailed statement.
The plant, which is located in Lancaster, Pa., was recently inspected by the FDA, according to the company. The facility received a Form 483, which is issued after an FDA inspection yields unsatisfactory results for compliance with regulations or a violation of good manufacturing practices.
The facility is operated by Johnson & Johnson-Merck Consumer Pharmaceuticals, a joint venture of J&J and Merck that develops and markets OTC drugs derived from Merck's prescription medicines. The unit makes heartburn relievers Mylanta and Pepcid and multi-symptom relief drug Imodium.
"JJ/MCP takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible," the companies say in a statement, as quoted by CNN. "We will provide a detailed response to the FDA and work diligently to address all observations."
This latest news isn't good for the drugmaker: "It shows that there is a systemic issue at the company and management has to do a better job in bringing the facilities into compliance with FDA regulations," says Bill Khurani, founder of Antrix Inc., a regulatory affairs & quality assurance consulting firm, as quoted by CNN.
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- see Reuters' coverage