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Quality / Medical Devices / QSR / Postmarket Safety

FDA Warns ProSun Over Failure to Correct Tanning Bed Exposure Time

Nov. 21, 2017

The FDA issued a warning to Florida-based ProSun International over significant GMP and branding violations revealed during an August inspection.

The agency had previously notified the firm that its ProSun SunDream residential tanning beds were labeled with a maximum exposure time of 30 minutes, that is up to three times higher than what the agency recommends.

But the company’s correction failed to resolve the issue. ProSun sent a letter to customers notifying them of changes made to the devices, including a new timer knob and an updated manual. But the “numbers corresponding to minutes did not change,” the agency said.

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