Oct 10, 2017
New Report Shows FDA Inspection Team Isn't Very Effective
A review of the FDA’s food safety inspections procedures isn’t very confidence-inspiring.
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New Report Shows FDA Inspection Team Isn't Very Effective
A review of the FDA’s food safety inspections procedures isn’t very confidence-inspiring.
FDA Enforcement Intensified in 2025 Persistent Supplier Compliance Failures in Focus The year 2025 will be remembered as a pivotal turning p
FDA Enforcement Trends 2025: Impact on GMP Compliance | PHARMALANE UK
Discover how FDA enforcement intensified in 2025 and what it means for pharmaceutical compliance, GMP inspections, and regulatory risk management.
FDA Inspections Recommencing: Be Prepared - An NSF Guide
Are You Ready for an FDA Inspection? FDA inspections recommence on February 7, 2022. Are you ready? Sanjay Shetgar from NSF International has created a useful guide to help you prepare.
The 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. India and China belong to these categories. The FDA plans to restart additional foreign surveillance inspections in April.
Companies need to be ready for the restart of FDA inspections. NSF International’s global team of pharmaceutical and biotech experts is already assisting companies with their preparations.
For more information visit @ https://www.pharmafocusasia.com/articles/fda-inspections-recommencing-be-prepared-an-nsf-guide
FDA Inspections And ISO Audits - FDA conducts an inspection and inspects the Quality System using investigators whereas ISO conducts an audit and registrars conduct audits using auditors.
FDA Inspections And ISO Audits
As you can see there is a huge difference in inspection and audit, Audit is an independent review and examination of records and activities to assess the adequacy of system controls, to ensure compliance with established policies and operational procedures, and to recommend necessary changes in controls, policies or procedures, it is just to determine the authenticity and validity or to ensure that a process is being followed.
FDA Inspections vs ISO Audits : FDA 21 CFR Part 820 and ISO 13485
FDA Inspections And ISO Audits
As you can see there is a huge difference in inspection and audit, Audit is an independent review and examination of records and activities to assess the adequacy of system controls, to ensure compliance with established policies and operational procedures, and to recommend necessary changes in controls, policies or procedures, it is just to determine the authenticity and validity or to ensure that a process is being followed.
In the same way, inspection makes a difference as it indicates that the regulatory authorities are checking documents, records, facilities and any other resources to verify a certain set of standards. It is the act of examining something, often very close.
FDA conducts an inspection and inspects the Quality System using investigators whereas ISO conducts an audit and registrars conduct audits using auditors. The two are planned and conducted differently and their conduits have different levels of authority. It does matter to know the difference.
ISO 13485:2016 is a voluntary standard for Quality Management Systems of medical device manufacturers and suppliers and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices. One of the main reasons that ISO 13485 has been revised is the alignment of the international standard with the common regulatory concepts that have evolved since 2003. ISO 13485 has been affected by the leading medical device regulatory bodies around the world, like the FDA (Food and Drug Administration) in the United States.
The medical device regulatory processes have progressed a lot since 2003. Increased regulatory emphasis on product safety, requirements for risk management in products and processes, and improvement of reporting systems to regulatory bodies led the revision of ISO 13485 in 2016. The revision was made to help users to meet common regulatory requirements.
The relationship between ISO 13485:2016 and FDA 21 CFR Part 820
ISO 13485:2016 helps organizations to maintain an effective Quality Management System that addresses the applicable regulatory requirements. The latest ISO 13485 standard also encompasses common regulatory concepts within its requirements. Organizations based on this standard can move towards compliance with FDA 21 Code of Federal Regulation (CFR) Part 820 (Quality System Regulation). Based on their compliance with this regulation, organizations can market medical devices commercially in the U.S. Part 820 defines requirements for the quality system to meet FDA regulations, termed current good manufacturing practices. It is more similar to ISO 13485 as far as requirements are concerned. Other Parts include (for example) Part 810, which deals specifically with the procedure of medical device recall, and Part 830, dealing with unique device identification of medical devices.More info:http://bit.ly/2qNMmr2
David R. Dills is a regulatory affairs & compliance consultant having extensive experience and knowledge in regulatory affairs, compliance and quality systems.
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New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them
New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them
The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating to food transportation. This is something required by the Food Safety…
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