FDA EIR - Powdersize, LLC dba Microsize - December 18, 2019

A comprehensive FDA surveillance inspection of Powdersize, LLC dba LONZA, a contract micronizer specializing in human and veterinary active pharmaceutical ingredients, excipients, and food-grade products for food and dietary supplement applications, was conducted from December 11-18, 2019, in Quakertown, PA. The inspection evaluated compliance with multiple regulatory frameworks, including programs for Active Pharmaceutical Ingredients, Animal Drug Manufacturing, Preventive Controls for Human Food Operations, and Dietary Supplements, including 21 CFR 111. While no FDA Form 483 (Inspectional Observations) was issued, several significant discussion items were raised with management. Key issues included the firm’s previous policy regarding process validation for commercially marketed drug products, which was initially deemed customer-discretionary rather than a required firm process (a correction was made during the inspection to address this). Furthermore, deficiencies were noted in the firm’s food safety plan: it did not formally identify sanitation as a preventive control, nor did it explicitly list metal as a potential hazard at the final metal detection processing step. Management acknowledged these observations, promising to implement the necessary corrections to ensure full compliance with regulatory expectations.