FDA WARNING_LETTER - UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) - December 02, 2010

On April 5, 2011, the FDA issued a Warning Letter to UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) following an inspection from November 30 to December 2, 2010, at their Martinez, Georgia facility. The inspection revealed that The Medical Extender Device (also known as the Andro Penis Extender) is adulterated under 21 U.S.C. § 351(h) for non-conformity with current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Specific violations for The Medical Extender Device included failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)), with no documented procedure, and complaints not being evaluated for MDR reporting or investigation necessity. The firm's December 15, 2010, response was deemed inadequate as no procedures were provided, and no review of prior complaints was performed.

Additionally, The Medical Extender Device was found misbranded under 21 USC 352 (t)(2) for failing to furnish required information under 21 USC 360i and 21 CFR Part 803 (Medical Device Reporting - MDR). This included a failure to develop, maintain, and implement written MDR procedures (21 CFR 803