FDA WARNING_LETTER - ProSun International, LLC - August 04, 2017

On October 25, 2017, the FDA issued a Warning Letter to ProSun International, LLC, following an inspection from August 1-4, 2017. The inspection revealed that ProSun, a manufacturer of Class II medical device sunlamps/tanning beds (Product Code LEJ), had adulterated devices due to non-conformity with the Quality System Regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish finished device acceptance procedures (21 CFR 820.80(d))**: Issues included lack of correlation between radiometer readings and supplier measurements, inadequate "max" specifications for UV readings, and insufficient documentation of functional testing for multiple units. The firm's response was deemed inadequate as it lacked objective evidence and failed to address discrepancies. 2. **Failure to establish corrective and preventive action procedures (21 CFR 820.100(a))**: The firm's CAPA procedure was inadequate, lacking requirements for analyzing quality data, verifying/validating corrective actions, and identifying actions to prevent recurrence. A previous Warning Letter's issue regarding a 30-minute Maximum Recommended Exposure Time (MRET) for the SunDream tanning bed, which was three times higher than FDA recommendations, remained uncorrected. 3. **Failure to establish document control procedures (21 CFR 820.40)**: The firm