# FDA WARNING_LETTER - Subcon Manufacturing Corporation - January 31, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/subcon-manufacturing-corporation/614dc505-22c4-4cfc-b71c-89961b20f7a1

> FDA WARNING_LETTER for Subcon Manufacturing Corporation on January 31, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Subcon Manufacturing Corporation
- Inspection Date: 2012-01-31
- Product Type: Devices
- Office Name: Chicago District Office
- Summary: An FDA inspection of Subcon Manufacturing Corporation, a contract manufacturer of LED skincare and teeth whitening systems, was conducted from January 10-31, 2012. The inspection revealed significant violations regarding the Evado Model 1029 and Revitalight Skin Care System Model SSE-1000, which are classified as medical devices. The Evado Model 1029 was found to be adulterated under 21 U.S.C. § 351(f)(1)(B) due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). It was also misbranded under 21 U.S.C. § 352(o) and 21 CFR 807.81(a)(3)(ii) for introducing the device with major changes to its intended use without submitting a new 510(k) premarket notification, specifically promoting new indications beyond its original clearance. Similarly, the Revitalight Skin Care System Model SSE-1000 was deemed adulterated for lacking PMA/IDE approval and misbranded under 21 U.S.C. § 352(o) and 21 CFR 807.81(a)(3)(i) for failing to notify FDA of device modifications, such as combining red and blue light for acne treatment, which requires a new premarket submission. Subcon Manufacturing Corporation is required to immediately cease activities leading to the misbranding or adulteration of these devices. The firm must provide a written response within fifteen working days detailing corrective actions, prevention plans, and a timetable for completion. Failure to comply may result in regulatory actions including seizure, injunction, or civil money penalties, and may impact federal contract awards.

## Related Officers

- [Scott J. Macintire](https://www.globalkeysolutions.net/people/scott-j-macintire/ca3dc0d0-ffd3-4d61-bd98-56aa7d8b15af)

Company: https://www.globalkeysolutions.net/companies/subcon-manufacturing-corporation/34c35153-fd6e-4bbd-b000-ecf31ce8e165

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669