FDA EIR - MPP GROUP, LLC - September 11, 2018

An FDA inspection of MPP Group, LLC, a dietary supplement, device, and drug manufacturer in Mequon, WI, was conducted from September 6-11, 2018. This initial, routine inspection specifically focused on the firm's dietary supplement operations, governed by 21 CFR Part 111 (Dietary Supplement cGMPs).The inspection resulted in five significant observations documented on an FDA Form 483. Key issues included the company's failure to verify the identity of dietary ingredients prior to use and the absence of quality control approval for quarantined components before manufacturing. Additionally, MPP Group, LLC had not qualified suppliers to rely on their certificates of analysis for contaminant limits, failed to ensure quality control approved and released finished product batches for distribution, and did not have the Master Manufacturing Record readily available.Several verbal observations also highlighted non-compliance, such as the lack of written procedures for product returns, holding supplements, or equipment cleaning, and insufficient review of environmental monitoring records by quality assurance. Labeling concerns included the absence of a clear statement of identity on outer packaging, incomplete identification of botanical plant parts, and potentially unproven therapeutic claims related to magnesium deficiency. Furthermore, certain fiber products contained ingredients typically found in over-the-counter drugs but were marketed as dietary supplements.MPP Group, LLC acknowledged all observations, agreeing to implement corrective actions and submit a detailed plan within 15 working days.