Catalent Micron Technologies, Inc. – FDA 483, Jun 9, 2025

An FDA inspection conducted at Catalent Micron Technologies, Inc., an API manufacturer, during June 2-5 and June 9, 2025, revealed critical deficiencies in their operational practices. The inspection, resulting in an FDA Form 483, highlighted four main observations indicating non-compliance with Good Manufacturing Practices. Firstly, the company failed to establish and adhere to procedures for managing rejected drug products. Containers of finished API that did not meet specifications were found incorrectly labeled as "QA Released," not segregated, and their batch's Certificate of Analysis inaccurately reported acceptable results, posing a risk of distribution of non-conforming products. Secondly, equipment cleaning procedures were inadequate, lacking accessibility in the washroom and comprehensive, detailed instructions for various equipment components, specific cleaning solutions, and post-cleaning storage. Thirdly, electronic raw data from laboratory instruments lacked sufficient data integrity controls, allowing for potential deletion or modification of original analytical records. Lastly, production equipment was not properly maintained; damaged product-contact surfaces exhibiting visible pits and grooves were not identified during preventative maintenance, which could lead to product contamination and hinder effective cleaning. Catalent Micron Technologies is expected to implement thorough corrective and preventive actions to address these serious issues and ensure adherence to regulatory standards for drug quality and safety.