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FDA holds J&J under magnifying glass

Friday, January 13, 2012 01:34 PM

The FDA has trained a watchful eye on Johnson & Johnson as delayed reports, recalls and court trials pile up.

“I think the FDA, now that it has its eyes on J&J, is taking a look at everything," Les Funtleyder, analyst with Miller Tabak, told the Star-Ledger. "There's no question, the FDA is getting more stringent.”

The FDA posted a letter on its web site Jan. 10 warning J&J that it could face fines and injunctions if the company’s Animas unit, which failed to report malfunctioning insulin pumps, does not detail within 15 days how it will improve the problems, according to the Star-Ledger.

Companies are required to report malfunctions within 30 days, but in two cases Animas waited several months to inform the FDA that patients using the company’s pumps had to be hospitalized, according to a Star-Ledger report.

The FDA has reprimanded J&J for several other quality control issues in the past two years, according to the Star-Ledger. Although one plant has resumed shipping, the central plant of a massive recall remains shut down.

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