(Chicago) March 7, 2010 — Though 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, one of the Web’s leading sources on the business of the FDA.

Last year, the FDA issued 9,910 Form FDA 483s to FDA-regulated companies, the highest number in 10 years, FDAzilla researchers concluded. Also, the number of Form FDA 483s specifically issued to pharmaceutical and biotech companies (1,500) was a 10-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 may 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 Form FDA 483

Under its mandate, the FDA has authority to inspect factories that manufacture products regulated by the agency.  Inspectors can show up and inspect any given facility at any time, and they record their observations on a form called a 483.

While 483s technically aren’t legal sanctions, companies ignore them at their peril, experts note. If drugmakers don’t respond to them appropriately, or are cited for repeat violations, they can be hit with much more serious Warning Letters or even be forced into multimillion-dollar Consent Decrees.

Still, FDAzilla analysis concluded that many manufacturers are making dangerous process errors, failing to document key procedures or otherwise neglecting the fundamentals of 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 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 hundreds of Form FDA 483s from 2009 and 2010 to learn what issues were most important to FDA inspectors.  FDAzilla found

The report, “Top Seven Strategies for Avoiding 483s: Pharma and Biotech Sector,” offers a detailed 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 FDAzilla.com or call Tony Chen at 312-725-3545.  Reports may be made available at no charge to qualified members of the press.

About FDAzilla
FDAzilla (www.fdazilla.com) is a business intelligence company on a mission to help professionals work smarter with the FDA.  We provide a variety of tools that make FDA-related data more usable, searchable, and most of all, actionable.  Mentioned in MSNBC’s front page story on Triad, our website is viewed more than 70,000 times/month and is quickly becoming known as an online leader of providing FDA data.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

by Tony Chen

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