Blog
The U.S. Food and Drug Administration (FDA) conducts on-site investigations for organizations that manufacture and package drugs to protect patient safety and maintain a high-quality standard in the life science industry. Both start-ups and enterprise pharmaceutical companies will be the subject of and FDA audit when any new product is launched.
What is a Warning Letter?
Conducting an FDA inspection may be necessary for your company to achieve compliance, which can pose challenges if you aren’t sure what is expected. If the FDA inspector observes conditions that violate the current regulatory standard, they may issue an FDA warning letter. Each warning letter includes detailed 483 observations for why your manufacturing facility is non-compliant. Your operations team will need to work with regulatory experts to prepare a response and action plan for FDA review and approval.
How many Pharma companies receive warning letters?
According to our partners at Redica Systems, the FDA sent at least 175 warning letters to small molecule drug and large molecule biologics manufacturers during fiscal 2023. Additionally, the regulatory compliance team at the FDA issued different types of warning enforcement & 483 observations that varied based on the corrective action and preventative action needed. Though receiving an FDA warning letter is not the end of the world, your company must understand the letter and respond appropriately with an action plan that returns your company to regulatory compliance.
Depending on your company’s regulatory response to the letter, the FDA may close out the investigation or take FDA 483 legal action if deemed necessary.
What is a Pre-Approval Inspection (PAI)?
Finally, it may be beneficial for your Quality Assurance team to conduct a FDA pre-approval inspection before a product comes to market to help refine standard operating procedures (SOP) for your quality management system (QMS).
Our PAI FDA clients have found this service to enhance their compliance many times over. RCA also can provide training for the FDA’s Pre-Approval Inspection (PAI) Program before the remediation efforts to help mitigate the situation. We adjust all our services to the needs of each client to help ensure the FDA’s concerns are addressed and compliance is achieved.
