FDA Sends Johnson & Johnson Warning Letter on Two Products
In a letter to J&J's DePuy Orthopaedics, the FDA says it has learned that the company is marketing the TruMatch without the required marketing clearance or approval and in violation of the Federal Food, Drug, and Cosmetic Act. TruMatch Personalized Solutions System is a high-tech CT scanner that can create detailed 3-D views of a patient's knee for implant surgery.
The regulatory authority, which recently began a crackdown on medical devices, asked the company to submit information to gain marketing approval. "The FDA will evaluate the information you submit and decide whether your product may be legally marketed," the letter stated.
The other product, the Corail Hip System, was cleared, the FDA says, and indicated for cementless use only. But the company marketed the hip replacement for two unapproved uses, as mentioned in the brochure that used to be on its website.
DePuy has 15 days to notify the FDA of the specific steps it has taken to correct the violations. It also wants an explanation of how the company plans to prevent these violations or similar ones from occurring again.
It's been nearly a year now that Johnson & Johnson's reputation has been marred with one recall after another and manufacturing and quality control issues that left one of its plants closed since April. The problems at its McNeil Consumer Healthcare unit triggered a massive recall of children's Tylenol and other over-the-counter medicines.
The company started feeling the effect of the recall with consumers shying away from its products, and second-quarter sales were lowered by $200 million. It expects the effects of the recall to be $600 million for the year, according to the Wall Street Journal.
Last week, CEO William Weldon said in an interview with the WSJ that the company is reorganizing its manufacturing side and creating a new position to ensure quality production across the company. Weldon said the problems at McNeil were limited to the unit -- an "outlier" in the company. But only Monday J&J announced yet another recall, this time of its 1 Day Acuvue contact lenses in Japan and a few other countries in Asia and Europe.
The FDA's Office of Criminal Investigations is already looking into the recalls at McNeil, and execs had to testify in front of a Congress committee. And according to CNNMoney sources, the FDA might soon start bringing criminal charges against high-ranking executives at companies that have issued a number of recalls due to manufacturing violations. Adding illegally marketed devices can't help.