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Follow on Google News | Report Documents Dramatic Increases In Form FDA 483 Citations For Pharma and Biotech FirmsThough it can cost hundreds of thousands of dollars to respond to a single Form FDA 483, many pharma manufacturers aren’t taking some of the basic steps needed to avoid being cited, according to new research published by FDAzilla.
By: FDAzilla In 2010, the FDA issued 9,910 Form FDA 483s to FDA-regulated companies, the highest number in ten years, FDAzilla researchers concluded. Also, the number of Form FDA 483s specifically issued to pharmaceutical and biotech companies (1,500) was a ten-year high as well. These were issued not only to small drugmakers with tiny quality assurance staffs, but also giants like Baxter, Amgen, and Pfizer, the report notes. “Our research suggests that the FDA will hand out even more 483s this year,” notes Tony Chen, CEO of FDAzilla. “It’s more critical then ever to be prepared for inspections.” About the FDA 483 The FDA has authority to inspect factories that manufacture products regulated by the agency. Inspectors can inspect any given facility at any time, and they record their observations on a form called a 483. While FDA 483s technically are not legal sanctions, companies ignore them at their peril, experts note. If drugmakers don’t respond to them appropriately, comprehensively, and swiftly, or are cited for repeat violations, they can be hit with much more serious Warning Letters or even be forced into multimillion- Still, FDAzilla analysis concluded that many manufacturers are making dangerous process errors, failing to document key procedures or neglecting the fundamentals of validation and quality control — perhaps because correcting these errors can itself be costly and time-consuming. Even when the FDA doesn’t crack down, sometimes manufacturing errors don’t come to light until events like the 2008 heparin manufacturing scare — during which hundreds of patients suffered adverse reactions due to problems at a Chinese drugmaking plant contracted to Baxter. More recently, contamination and sterilization problems at a Triad Group (H & P Industries) plant led to multiple articles and front-page coverage at MSNBC. Critical issues for FDA Inspectors To take the pulse of the FDA inspection program for drugmakers, researchers sampled more than 200 Form FDA 483s from 2009 and 2010 to learn what issues were most important to FDA inspectors. The new report, “Top Seven Strategies for Avoiding 483s: Pharma and Biotech Sector,” offers a comprehensive view of these issues, plus highly detailed information from top former FDA compliance officials, consultants, senior attorneys working with the FDA and quality leaders within major biopharma organizations. With this report, drugmakers will have an indispensable tool for: * Preparing staff for inspections * Noticing small details before inspectors do * Staying on top of FDA priorities * Satisfying critical documentation requests promptly and appropriately * Bulletproofing validation processes ….and much more. Our report is designed to give drugmakers the knowledge, context and data needed to satisfy inspectors whenever they appear. To learn more about the report, or the wealth of additional data and insights we offer on the FDA, visit http://www.fdazilla.com/ — About FDAzilla FDAzilla (www.fdazilla.com) # # # FDAzilla provides business intelligence for professionals to work smarter with the FDA. We provide a variety of tools that make FDA-related data more usable, searchable, and most of all, actionable. End
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