# FDA WARNING_LETTER - Sun Technologies, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/sun-technologies-inc/43b36714-da25-4e47-8ef2-68c059be7ae7

> FDA WARNING_LETTER for Sun Technologies, Inc. on Unknown Date. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sun Technologies, Inc.
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/lynne-l-rice/95243ead-e958-4d6f-93e9-e53054aacb62)
- [Varsha B. Savalia](https://www.globalkeysolutions.net/people/varsha-b-savalia/48a08189-b36d-489f-a1e1-71fb16252206)

Company: https://www.globalkeysolutions.net/companies/sun-technologies-inc/030c4a0c-9701-43a0-bc90-616166165c2b

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7