How to Respond to FDA Form 483s and Warning Letters
July 10, 2017
Many medical device manufacturers receive FDA warning letters due to lack of preparation for the FDA inspection and/or an inadequate response to an FDA Form 483. The manner in which manufacturers respond to the 483 is critical in mitigating potential compliance risks and preventing the issuance of a warning letter. This article by NSF’s Kristen Grumet, published in Medical Design and Outsourcing, explains six key steps manufacturers can take when issued the FDA Form 483.
How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
What’s New with NSF
Brooklands New Media’s Publication On NSF’s Global Animal Wellness Standards (GAWS) Not Endorsed by NSF
November 25, 2024NSF is aware that a firm called Brooklands New Media plans to publish a book to mark the 5th anniversary of NSF Global Animal Wellness Standards (GAWS).
Read the Story
NSF Announces Participation in Sustainable Foods 2025, CNBC Docuseries
November 18, 2024In January 2025, Lisa Spicka de Bevacqua, NSF’s Director of Sustainability Consulting, will speak at the Sustainable Foods 2025 International Conference and Exhibition in London, UK.
Read the Story
NSF Opens Advanced Water Testing Laboratory in Germany
October 17, 2024European manufacturers gain a competitive edge with local NSF/ANSI/CAN 60 and 61 certification testing.
Read the Story
World Food Day: A Global Call to Action for Food Security and Sustainability
October 16, 2024NSF marks World Food Day – a global call to action to raise awareness about the pressing issues of hunger, food security and the importance of sustainable food systems. Established by the Food and Agriculture Organisation (FAO) of the United Nations, this day reminds us of the need to ensure that everyone, everywhere, has access to enough nutritious food.
Read the Story