Lymol Medical Corporation – FDA Warning Letter, Feb 5, 2019

The FDA issued a Warning Letter to Lymol Medical Corporation on January 8, 2019, for failing to comply with a postmarketing requirement (PMR) for Sterile Talc Powder® (NDA 21388). The violation, concerning from a public health perspective due to lead content in sterile talc, impedes the evaluation of potential toxicities.

Lymol was required to complete PMR 3332-1: "Perform a risk assessment study on the lead content of sterile talc powder and indicate any necessary controls on elemental impurities as per ICH Q3D Elemental Impurities: Guidance for Industry," with a final report submission deadline of May 2018.

Lymol failed to submit the final report by the deadline and did not respond to subsequent FDA notifications regarding the missed milestone and failure to provide good cause for noncompliance. This constitutes a violation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act and renders Sterile Talc Powder® misbranded under section 502(z).

The FDA requires Lymol to submit the final study report for PMR 3332-1 within thirty calendar days of the letter's date. Failure to correct this violation may result in regulatory actions, including civil money penalties. Lymol is also advised to contact the FDA's Drug Shortages Staff if any action is likely to disrupt the supply