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.
The devices, which are classified as class II medical devices and require premarket approval, were also misbranded because the firm failed to submit a written report to the FDA on its field correction.
The warning letter listed seven GMP violations related to the firm’s procedures for finished acceptance of incoming products, CAPA actions, handling complaints, conducting quality audits, as well as controlling documents and environmental conditions.
For example, ProSun’s procedure for establishing CAPA actions were deemed inadequate because it lacked requirements for analyzing quality data and for ensuring that an action would not have an adverse effect on a device. The procedure also failed to identify actions to correct and prevent quality problems, the FDA said.