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What’s Next and How It Will Work
Unannounced inspections at foreign manufacturing facilities are seen as a necessary step in protecting American consumers and improving the quality standards at these sites by deterring fraud, safety risks, and the falsification of records by manufacturers. After announcing the expansion of the pilot programs in key territories like India and China, the federal agency is also taking further steps to ensure inspections are done with integrity by introducing new travel and accommodation policies to avoid conflicts of interest. The inspections will affect manufacturers in over 90 countries who manufacture and sell food and medicinal products to Americans, which means from now on, every manufacturer who exports to the U.S. must conduct a self-assessment and check to see if they are aligned with FDA guidelines on an ongoing basis to avoid being caught off guard. As a foreign manufacturer, in addition to being inspection-ready at all times, it is important to ensure you keep up-to-date records (e.g., batch production records, equipment, calibration logs, CAPA reports), maintain proper documentation that meets FDA’s ALCOA+ standards for data integrity, and make sure you have qualified personnel including at least one QA manager available during inspections at your facility consistently to avoid any inspection delays, as the FDA will impose regulatory action for any attempt to delay, deny, or block inspection, which will result in costly penalties and, even worse, a potential ban on import privileges, which would result in the loss of substantial revenue for your business.
Why Permanent Inspection Readiness Is the Way to Go
As a manufacturer, Good Manufacturing Practices (GMP) and quality should always be embedded in your manufacturing process and products from the word go not just as a means of passing an inspection, but to set yourself apart from the pack. PQE Group has always stood for quality in life sciences manufacturing, advocating for quality by design and not as an afterthought, as a way of promoting long-term compliance and prioritizing patient safety and product integrity across the entire supply chain. Our structured and proactive approach to permanent inspection readiness means foreign manufacturers like you are always ahead and not reactive when it comes to FDA inspections. Guided by three core pillars: Design (gap analysis against regulatory benchmarks), Implementation (remediation aligned with FDA’s Systems-Based Inspection approach), and Realization and Control (continuous monitoring via KPIs like CAPA closure rates)our comprehensive program empowers you to rapidly identify compliance gaps to achieving continuous inspection readiness.. Rather than viewing inspection readiness as a one-time event, PQE Group sees it as a continuous process that you, as a manufacturer, need to embed into all aspects of your daily operations, from developing well-trained personnel to establishing a strong culture of accountability. Building compliance into the fabric of your organization has been and will always be the key not just to FDA compliance, but to long-term business success. Taking a structured approach like PQE Group’s three-pillar Permanent Inspection Readiness model, which includes assessment, remediation, training, mock inspections, and real-time support, means you are not just preparing for your next inspection, but ensuring continued success as a global manufacturer.
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