PMS4PMS, LLC Warning Letter Details

Summary

PMS4PMS, LLC was found to have violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in November 2024, rendering their drug products adulterated. The company failed to conduct appropriate laboratory testing to confirm that each batch met final specifications for identity and strength of active ingredients prior to release, as required by 21 CFR 211.165(a). Additionally, their product "Comforté® Menstrual Cramp RELIEF CREAM" was identified as an unapproved new drug and misbranded product introduced into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act. The company's response to the FDA's Form 483 observations was deemed inadequate due to lack of supporting documentation and insufficient evidence of corrective actions to achieve CGMP compliance.