FDA WARNING_LETTER - IPCH Management, Inc

The FDA issued a Warning Letter to IPCH Management for non-compliance regarding their Tootsie Tanner Model 127661-4002 portable foot tanner. The FDA's review of records and the company website revealed a failure to submit the required Radiation Safety Product Report, as requested on July 27, 2009.

Additionally, the user manual for the Tootsie Tanner exhibited several deficiencies: 1. **21 CFR 1040.20 (d)(1)(i)**: The warning statement was insufficient, requiring corrections to phrases like "CAUSE PERMANENT AGING" to "CAUSE PREMATURE AGING," "SENSITIVITY TO ULTRAVIOLET" to "SENSITIVITY TO THE ULTRAVIOLET," and "CONSULT PHYSICIANS BEFORE" to "CONSULT PHYSICIAN BEFORE." Also, the eye protection statement was not highlighted as required. 2. **21 CFR 1040.20 (d)(3)(i)**: The product lacked a legible and readily accessible exposure schedule for the user, as it was on the rear panel with poor contrast. 3. **21 CFR 1040.20(e)(1)**: User instructions were inadequate; for SKIN TYPE 4, the manual allowed 30 minutes exposure, exceeding the erythemal time (Te) of 20