FDA WARNING_LETTER - Sun Technologies, Inc.

The FDA issued a Warning Letter to Sun Technologies for introducing non-compliant tanning beds (SOLAR STORM 16, 24R, 28C, 32C) into commerce. The Center for Devices and Radiological Health (CDRH) identified multiple violations of federal regulations.

Key deficiencies include: 1. **Lack of Certification (21 CFR 1010.20):** No certification labels on beds or packaging, and failure to certify compliance with 21 CFR 1040.20 based on good manufacturing practices. 2. **Lack of Identification (21 CFR 1010.30):** No identification labels on beds or packaging. 3. **Inadequate Labeling (21 CFR 1040.20(d)(1)):** Absence of required warning statements, recommended exposure positions, exposure schedules, and lamp type designation. Exposure schedules in manuals exceeded safe erythema times, leading to potential overexposure. 4. **Adulterated Devices (FFDCA Section 501(c)):** Devices are adulterated due to non-compliance with performance standards. 5. **Misbranded Devices (FFDCA Sections 502(a), 502(c), 502(f)(1), 502(f)(2), 502(o)):** Labeling