483s Can Be a Good Thing (Really)

483s Can Be a Good Thing (Really)

Mark Crawford

According to FDANews, the increasing rate of FDA inspections and warning letters is continuing this year—as of June 2011 the FDA had issued 874 letters in fiscal 2011, compared with 673 last year. If FY 2011 is like 2010, leading issues will be quality unit deficiencies, inadequate batch failure investigations, lack of follow-up procedures, validation of manufacturing processes, and handling deviations. For international inspections, deficient laboratory controls, quality unit deficiencies, and deficient procedures led the list last year.

It usually starts with Form 483, which “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance.”

As casual as this sounds, don’t ignore the 483!

Sure, getting this notification is a drag, and depending on what needs correcting, can cost a lot of money to fix. But ignoring a 483, or being cited repeatedly for the same violation, can result in far worse, such as warning letters and consent decrees which can shut your operation down. For example, back in March, using a formal consent decree, the FDA closed a Johnson & Johnson plant in Fort Washington, Pennsylvania after identifying several process validation violations at the plant in December 2010.

Of course, the best way to avoid 483s is to meet (or better yet, exceed) FDA requirements. Quality is the name of the game—the better your processes and systems, the better the quality of your overall operation. This means easier validations, faster time to market, happier customers, and less scrutiny from the FDA because it actually begins to trust that you know what you are doing (and may actually know as much about their regulations as they do).

There are many ways to achieve this; first and foremost, a culture of quality must be present and starts with the highest executives

The right resources must be provided to produce top-level quality. Ideally a team of employees should be dedicated to (and educated in) Quality Assurance/Regulatory Assurance. Not all quality improvements have to be expensive—they can be as simple as doing some value-stream mapping to identify points of weakness in a process. Run your own audits on a regular basis—not only to find areas to improve, but to get staff experienced with the process so they handle a real FDA audit when it comes. Also obtain copies of actual 483s from the FDA that were issued to other companies within your industry and study them hard to be sure you aren’t making the same mistakes.

The website FDAzilla.com provides FDA-related intelligence that helps companies “work smarter with the FDA” by providing searchable FDA-related data. One section of the website is devoted to 483s and claims to be the “world’s only full-text index of FDA Form 483 observations issued.”

After poring over hundreds of 483 reports and interviewing various experts, including former FDA investigators, FDAzilla.com has identified seven key strategies for avoiding Form FDA 483s. Companies that are serious about quality conduct their own internal and third-party audits to improve their operations, which can involve considerable time and money. A Form 483 is actually a blessing in disguise—a free audit (no need for an expensive third-party consultant!) that identifies a deficiency that, when fixed, improves your process of doing business and prevents a more serious, or even tragic, event from happening down the road.

Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 25 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.

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