In 2024, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) took significant actions to ensure compliance with regulatory standards. This blog post highlights some of the most notable warning letters and non-compliance reports issued by these agencies.
FDA Warning Letters
The FDA issued numerous warning letters in 2024, addressing patient safety, product quality and data integrity violations. Here are some key examples:
Sanofi's Genzyme Corporation Facility: The FDA issued a warning letter to Sanofi for significant deviations from Current Good Manufacturing Practice (cGMP) for active pharmaceutical ingredients (APIs). The letter highlighted the following
failure to demonstrate that manufacturing processes can reproducibly manufacture an API product meeting its predetermined quality attributes
failure to have equipment of the appropriate design and suitability for their intended use for the manufacture of APIs
failure of the quality unit to exercise its responsibility to ensure the API manufactured are in compliance with cGMP
failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated, and the conclusions are recorded
Hologic, Inc.: After an uptick in patient complaints and a recall notice, an FDA inspection noticed significant violations related to the manufacturing of BioZorb implantable devices, including inadequate design control procedures or more specifically
failure to establish design inputs to ensure that the design requirements relating to a device are appropriate and address the intended use of the device
failure to verify the device design to confirm that the design output meets the design input requirements
failure to validate the device design to ensure that devices conform to defined user/patient needs and intended uses
failure to ensure that the device design is correctly translated into production specifications
failure to establish and maintain procedures for implementing corrective and preventive actions
A robust system development lifecycle with documented controls between critical stages from design to market is key to ensuring product quality, avoiding customer complaints and regulatory actions.
EMA Non-Compliance Reports
The EMA also issued several non-compliance reports in 2024, focusing on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) violations. Here are some notable examples:
Akriti Pharmaceuticals Private Limited: The Maltese Medicines Authority issued a statement of non-compliance with the requirements of Good Manufacturing Practice (GMP) to the Indian pharmaceutical company. During an onsite inspection the inspectors observed ineffective implementation of the quality management system, data integrity issues, unreliable stability studies, lack of control in production and packaging operations including cross contamination measures and deficiencies concerning analytical testing.
CGN Pharma GmbH: The German authority found during inspections that the company did not comply with the principles of Good Distribution Practice (GDP). In particular, there were problems with customer and supplier qualification, due diligence and the transport of medicines. In addition, inadequate documentation and non-compliance with regulations in outsourced activities were criticized.
Effective supplier management is crucial in a globalized world, where complex supply chains demand careful selection, clear agreements and oversight.
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