FDA WARNING_LETTER - Genesis BPS, LLC. - February 11, 2013

During an FDA inspection of Genesis BPS, LLC. from February 4-11, 2013, records for Pedi-Pak 75 mL Transfer Pack and Pedi-Pak Pedi-Syringe Filter 30 mL, 35 mL & 60 mL sets were reviewed. These products are classified as devices.

The inspection revealed that these devices are adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). They are also misbranded under section 502(o) because the firm failed to notify the FDA of significant modifications to the devices, as required by section 510(k) and 21 C.F.R. 807.81(a)(3)(i).

Specifically, modifications to the Pedi-Pak Pedi-Syringe Filter (cleared under K050805) and Pedi-Pak 75 mL Transfer Pack (cleared under BK850003) were made without 510(k) submission. These changes include a material change from a (b)(4) to DEHP-free (b)(4), and material changes to BPA-free, Latex-free, and no animal derived materials. These are considered significant modifications affecting safety or effectiveness,