FDA WARNING_LETTER - Mayer Laboratories, Inc. - February 07, 2011

The FDA issued a Warning Letter to Mayer Laboratories, Inc. following a January-February 2011 inspection, identifying significant regulatory violations for its Aqua Lube Personal Lubricant and Kimono MicroThin Latex Condom with Aqua Lube. The firm illegally distributed Aqua Lube since October 2010, despite its 510(k) application (K091801) being withdrawn and explicit FDA instruction not to market the device. Additionally, Mayer Laboratories distributed Kimono MicroThin Latex Condoms with Aqua Lube without new FDA clearance. The original condom (K946374) was cleared with silicone oil, and the lubricant change is a significant modification requiring a new 510(k) per 21 CFR 807.81(a)(3)(i).

These devices are consequently adulterated under section 501(f)(1)(B) of the Act due to lacking an approved PMA or IDE, and misbranded under section 502(o) for failing to submit a 510(k) notification as required by 21 CFR 807.100(a). The FDA mandates a written response within 15 business days detailing corrective actions, prevention plans, and a timetable, including plans for already distributed non-compliant devices. Failure to comply could lead to severe regulatory actions like seizure, injunction, civil penalties, and impact federal contracts.