Chinese inspectors will focus their reviews on production technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections. Read More

St. Jude’s Sylmar, Calif., plant, which makes most of its CRM products, should soon emerge from an FDA warning letter, CEO Dan Starks said on the company’s earnings call last month. Read More

Russian regulators are struggling to create guidance that will implement device registration rules that took effect in January 2013, but have yet to be fully enacted. Read More

Chinese inspectors will focus their reviews on production technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections. Read More

A spate of recent federal false claims cases involving the use of durable medical equipment underscore the government’s continued scrutiny of the segment, an attorney says. Read More

American Aesthetics Medical Supply, a Dallas-based maker of microdermabrasion systems and crystals, lacks appropriate procedures for its suppliers and receipt of incoming ingredients, according to an FDA warning letter. Read More

Mega Electronics, maker of the FemiScan Home Trainer incontinence device and the ME6000 biomonitor device, received an FDA warning letter for incoming inspection shortfalls and other quality issues. Read More

ArthroCare has agreed to pay a $30 million fine and enter into a deferred prosecution agreement to resolve a U.S. Department of Justice criminal investigation of stock price manipulation. Read More