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May 2009

Good and Bad Responses to 483s

Preparing a response to a Form FDA 483 can be a time-consuming and stressful process. It diverts resources from other activities and, if not managed properly, the process can be overwhelming. If a 483 response is well written, factually correct and complete, it will establish that the firm has taken or is in the process of taking appropriate corrective and preventive action. This can allay FDA concerns about the firm's compliance, and reflect positively on the organization. If the response is poorly written, contains errors or omits critical information, it can trigger additional inspections or a Warning Letter. If the firm submits inadequate responses to a Warning Letter, the firm is at risk for seizures, suspension of product approvals, injunctive action or possibly criminal prosecution. While this article is focused on 483 responses, the recommendations apply equally to Warning Letters.

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What is the FDA's Third-Party Inspection Program and pMAP?

Many medical device manufacturers do not realize they can save time, money and resources while satisfying inspection requirements by the FDA and other conformity assessment providers. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the FDA introduced the Inspection by Accredited Persons Program or Third-Party Inspection Program. Under this program, eligible Class II and III medical device manufacturers can turn to an FDA-accredited third party to perform U.S. regulatory inspections.

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ECA Deviation Mgmt & CAPA 2009
May 19-20, 2009, Vienna, Austria

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May 26-27, 2009, Dublin, Ireland

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June 8-11, 2009, New York, NY

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Did you know that a centralized event management approach to CAPA control can help medical device companies comply more effectively with the FDA and simultaneously allow for horizontal reporting between issues and events (e.g., deviations, customer complaints, nonconformances)?

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