Abbott Laboratories shares dropped 1.9% in morning trade Thursday after the Food and Drug Administration released a warning letter to the company about the way it manufactures its medical devices. Though Abbott recalled certain implantable cardioverter defibrillators, which are used to treat irregular heartbeats, in October, 10 of the medical devices were later shipped out and an additional seven were put into patients, the FDA said. In this and other issues, Abbott didn’t provide evidence of its corrective and preventive actions in its response to the FDA, the regulator said. If the letter’s points aren’t addressed promptly, the FDA said it may start regulatory actions such as seizure, injunction and civil money penalties, or there could be consequences for federal contracts or FDA approvals for related devices. Abbott leadership, which has 15 days to respond to the letter, “does not expect today’s warning letter to negatively impact products currently on the market, although it may affect new product approvals,” including approvals for devices expected in the fourth quarter, said UBS analyst Matt Miksic. He said to expect more information when Abbott reports first-quarter earnings results, scheduled for Wednesday premarket. Abbott shares have risen 21.9% over the last three months, compared with a 3.2% rise in the S&P 500 .
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