FDA EIR - Fagron, Inc - April 10, 2019

A follow-up FDA inspection of Fagron, Inc., an API repacker and OTC drug manufacturer in Saint Paul, MN, took place from April 3-10, 2019. This inspection was conducted as a follow-up to a Warning Letter issued on August 29, 2018, which cited non-compliance with drug manufacturing regulations and ICH Q7 GMP guidance for APIs. Previous violations included failing to transfer complete quality and regulatory information from API manufacturers to customers on Certificates of Analysis (COAs), inadequate control over quarantined materials, and deficiencies in the stability testing program for drug products like OTC Zinc Oxide Paste. While Fagron had reported corrective actions for some of these, the April 2019 inspection issued a new observation: the lack of a final quality approval process for outgoing COAs, leading to incorrect manufacturer details being distributed. Verbal observations also highlighted issues with an accelerated stability chamber's maintenance and calibration, and insufficient documentation for items in the quarantine area. Fagron management committed to implementing a robust COA approval process and improving controls for quarantined items and stability equipment.