Responding to 483s in a New Era of FDA Enforcement

“We are fixing the pathways to improve the effectiveness of our enforcement system”

 

“First, the FDA will set post-inspection deadlines.  When the FDA finds that a firm is significantly out of compliance, we expect a prompt response to our findings. …the firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action.”

 

Margaret Hamburg, MD

Commissioner of Food and Drugs

August 6, 2009

 

Your company has just been issued a 483.  When you respond, and what you say in your response, can reduce the risk of receiving a Warning Letter or other enforcement action.

In the past, it may have been months or years before the FDA took enforcement action.

Not anymore.  In this era of increased FDA enforcement, companies that receive a 483 may have only 15 days to respond and correct issues before a Warning Letter is issued and/or other enforcement actions are taken.  A timely and effective 483 response is increasingly important to avoid these negative ramifications.

How can you ensure that you are responding to 483s quickly and correctly?  In this 90-minute audio conference, former FDA Deputy Associate Commissioner for Regulatory Affairs Steve Niedelman will discuss what you must do, from the time the investigator signs his/her name until the FDA indicates “no further action is necessary.”

How You Will Benefit From Attending This Audio Conference:

• Learn to avoid the Top 10 483 observations issued at the conclusion of medical device and pharmaceutical inspections
• Discover the importance of the issuance of a List of Observations and what it means for future agency considerations
• Gain knowledge of the key components of timely and effective 483 response writing
• Find out what to avoid in your 483 response
• Explore the significance of building a transparent relationship with the FDA

Who Will Benefit From Attending This Audio Conference:

• ANYONE involved in inspections and responses to the FDA
• Regulatory affairs professionals
• GMP/QSR auditors
• QA/QC personnel
• General and corporate counsel
• Executive management
• Manufacturing directors and supervisors
• Risk management specialists

Steven Niedelman
Steven Niedelman is a senior consultant to the Health Care and Product Risk Management Groups at Crowell & Moring LLP, specializing in regulatory, enforcement risk management, and policy matters involving industries regulated by the Food and Drug Administration. Based on his knowledge of FDA requirements, policies and procedures, Mr. Niedelman provides insight, guidance and training in FDA requirements to manufacturers, importers, new product developers as well as those firms involved in or facing enforcement actions. He provides training and coaching to industry in all FDA requirements including quality systems requirements, inspection preparedness, postmarket obligations, and to executive management about FDA's expectations and their management responsibilities. Until July 2008, Mr. Niedelman served as Executive Vice President of Quintiles Consulting, a global consulting firm specializing in providing strategic advice, insight and guidance to the Medical Device, Pharmaceutical and Biologics industries. Mr. Niedelman retired from the U.S. Food and Drug Administration in 2006 after a 34 year distinguished career where he served as Deputy Associate Commissioner for Regulatory Operations and Chief Operating Officer. He provided direct oversight over the headquarters offices of the Office of Regulatory Affairs (ORA), and assured consistent interpretation of FDA's regulatory policies by directly overseeing the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations, and assisted in the day-to-day management of FDA's nearly 3,400 field staff responsible for investigative and laboratory operations. He served as ORA's principal liaison to the Ceter for Devices and Radiological Health where he was a member of the FDA/Device Industry Grassroots Initiative Steering Committee, the Global Harmonization Task Force (GHTF) Steering Committee, and the CDRH Postmarket Initiative Steering Committee.