Sponsored by:
FDA Inspections Recommencing: Be Prepared - An NSF Guide
he FDA has restarted unannounced inspections of manufacturing facilities.
The restart commenced on February 7. Inspections were halted in March 2020 with the outbreak of COVID-19. A limited number of inspections had restarted; however, they were again paused due to the emergence of the Omicron variant in December 2021. The agency plans to proceed with planned inspections in countries that have received country clearance and fall under the Centers for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendations.
Quality Systems Remediation 101
Strategic well-planned remediation is paramount to long-term sustainable corrections and corrective actions. Read this white paper by Maxine Fritz as she details a quality systems approach using the three Cs: company culture, communication and collaboration.
A company facing a laundry list of observations at the end of any regulatory inspection will likely react with great energy and purpose to fix each one. This reactionary approach will likely lead to disappointment when the next regulatory inspection reveals additional examples of the same or similar problems. It can rapidly become a repetitive cycle of failures resulting in chronic quality system/GMP non-compliance. This happens when the company focuses on the symptoms rather than the underlying causes, i.e. the systems. If the underlying systems are not corrected, inspection after inspection will identify examples of the same system weaknesses.
