Business Intelligence Solutions Releases A New Fda 483 & Warning Letter Response Report In A New Era Of Regulatory Enforcement
The FDA's enforcement arm is back in business! The number of Warning Letters issued in 2010 was significantly greater than those issued in earlier years.
- Baltimore, MD (1888PressRelease) December 17, 2010 - No medical device or pharmaceutical manufacturer wants to receive a Form 483 and/or Warning Letter from the US Food and Drug Administration (FDA) and failing to ensure a proper response to satisfy the FDA can be fatal to your business. .
For a copy of the report, visit BUSINESS INTELLIGENCE SOLUTIONS at www.busintellsol.com and click Download 483 Report Download icon on the company's home page.
Commissioner of Food and Drugs, Margaret A. Hamburg, M.D. has announced the following at a recent FDLI Conference in Washington DC:
• "The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible."
• "We must get the word out that the FDA is on the job."
• "[I]n some cases, serious violations have gone unaddressed for far too long" and that enforcement action "can be too long and arduous when the public's health is in jeopardy."
These statements, together with the new FDA 483/Warning Letter policy add up to a new era in FDA enforcement, and one that will require the most experienced and capable team to ensure your don't risk your business by being unprepared.
BUSINESS INTELLIGENCE SOLUTIONS, a Microsoft partner specializes in helping companies who have received a warning letter or a 483 has issued a new report titled, "483 and Warning Letter Response Report" which can be downloaded at the company's website - www.busintellsol.com.
In the new report there are a number of steps you can take to avoid a 483 or Warning Letter:
DO:
• Unless you are an expert in FDA 483 responses, get an expert in FDA response preparation to assist you, right away, with the response to the enforcement action!
• Respond within 14 calendar days (10 business days) regardless of whether you are completely ready to respond or not.
Don't
• Be late with your response. It does not matter how busy you are - you must get the response in timely.
• Although there is no regulatory limit on when your responses have to be in, the Agency will perceive your lack of concern from the timeliness of your responses.
The second half of the compelling report deals with Quality Systems which has historically been an expensive, although necessary, proposition for the life science industry as it becomes more globally challenged. Ideas for reducing compliance costs are provided and examples of solutions to avoid 483s and Warning Letters and accelerate time to market are mapped out.
For a copy of the report, visit BUSINESS INTELLIGENCE SOLUTIONS at www.busintellsol.com and click Download 483 Report Download icon, which is located on the company's home page.
BUSINESS INTELLIGENCE SOLUTIONS, a Microsoft Partner specializes in providing regulatory products, information technology and professional services to FDA regulated industries that accelerates innovation and streamlines compliance.
Through our network of consultants and partner solutions, we have helped hundreds of FDA regulated companies design, integrate, support and validate regulatory processes and critical software applications.
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