Current Events

The U.S. Food and Drug Administration (FDA) has raised concerns over manufacturing controls at a Teva Pharmaceutical Industries plant in China, Israel's biggest company said in a regulatory filing on Thursday.

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The U.S. Food and Drug Administration issued a warning letter to Abbott Laboratories, citing manufacturing flaws with a range of cardiovascular devices acquired with its purchase of St. Jude Medical in January for $25 billion.

The letter, dated April 12 and made public on Thursday, sent Abbott's shares down 2 percent to $42.
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The US health regulator has issued a warning letter to drug firm Mylan for violations of good manufacturing norms, including data integrity lapses and failure of quality control at its Nashik facility.

The letter by the United States Food and Drug Administration (USFDA) to the Mylan Pharmaceuticals Inc President Rajiv Malik states that it had inspected the Nashik facility of the company from September 5 to 14, 2016.

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Cook Medical this week released information on a select voluntary recall of its Bush DL and Bush SL ureteral illuminating catheter sets over issues with overheating.

The Bloomington, Ind.-based company said it has received an increased number of reports of the proximal black component that connects to the distal transparent component overheating and melting, which could potentially cause burns.

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Inspectors with the U.S. Food and Drug Administration on Wednesday slapped St. Jude Medical with a warning letter accusing the medical device maker of failing to properly investigate problems with the batteries in its implantable defibrillators and the cybersecurity of its at-home monitoring equipment.

The inspectors said that company officials systematically underestimated the true risks facing heart-device patients, even after one person died in 2014.
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Over the past several years, there have been multiple recalls involving implant devices because of the dangerous risks they pose to patients. These recalls have included devices use for hip replacement and for knee replacements. Recently, the Food and Drug Administration announced a new recall — this time for shoulder implant devices.

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Dublin-based Medtronic plc said this week that an increase in product complaints prompted a Feb. 22 recall of all unused units of the StrataMR adjustable valves and shunts.

Roughly 2,622 of the affected devices had been distributed worldwide, and the company said the product’s complaint rate as of April 1 was 2.75%.

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A Queens man who was severely burned and temporarily had to use a wheelchair when an e-cigarette battery exploded in his pocket is suing the company that distributed the device.

It’s been four months after Otis Gooding’s Wismec Reuleaux RC200 vape instrument blew up while he was at work at the Central Cellar wine shop in Grand Central. But he still feels the pain.

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Due to problems with oversight and contract issues, the Medicare Fee-for-Service Program wrongly made payments of $41.1 billion in 2016, according to a GAO report.

Following an HHS report that initially found the inappropriate payments in the program, GAO noted that Medicare administrative contractors (MACs) conduct provider education to ensure fee-for-service payments. GAO observed and examined MAC operational procedures as the focus of its report.

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Drugmaker Mylan NV failed to investigate why medications made at a factory in India didn’t meet quality standards and frequently didn’t report the substandard results from its tests, the U.S. drug regulator said.

The quality system at Mylan’s facility in Maharashtra, India, “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the Food and Drug Administration told the company in a warning letter dated April 3 that was posted Tuesday. The shares fell as much as 2.
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It’s bad enough for family members when a loved one dies.

Getting cheated by Uncle Sam afterward makes it worse.

He did that in cases involving more than 2,000 beneficiaries who didn’t get the full benefit of U.S. Postal Service life insurance policies.
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