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While most firms do a careful study of 483s past and present that may have hit their facility, too few are taking a look at 483s issued to other firms, experts say. Sometimes you’ll catch up on issues you hadn’t considered, and what’s more, get tipped off as to what the agency is worried about […]

Courtesy of one of seasoned compliance and quality directors we talked to, here’s some practical advice for the actual day of the inspection: Ensure that the staff projects a calm confidence of their processes and procedures so they can speak to them clearly and accurately. Make sure everyone stays “on point”, particularly for discussions of […]

Meanwhile, U.S. inspections continue to be challenging, observers say, in part because the agency’s priorities and definition of cGMP continue to evolve. In previous years, quality assurance managers at pharma manufacturing plants knew more or less what to expect from an inspection. The inspections would take place every 24 months or so, and inspectors and […]

The FDA is rapidly scaling up the number of inspections it conducts of foreign drug making plants. This year, the agency plans to complete about 2,000 international inspections, and the evidence suggests that this number will continue to grow in FY13. Avoiding 483s in this environment may be tougher than in American plants, since the […]

In recent times, the FDA has stepped up its actions against pharmaceutical manufacturers, with 483s escalating to warning letters, warning letters to consent decrees far more quickly than it has in the past. What’s more, FDA officials have warned that it might go after individual executives and slap them with charges, which could impact or […]

During this August, FDA 483s month here at FDAzilla, we repost some of our favorite pieces related to 483s. Here’s one from the QA Pharm. Compliance to current good manufacturing practice (cGMP) regulations is, in fact, a part of normal pharmaceutical business that requires diligent management oversight. Just as it is with other business functions, […]

Today we have the privilege of interviewing former FDA investigator, LuisChavarria. After 30 years of conducting, managing, and supervising inspections, his insights are worthy of heavy consideration. 1. What do you think are the biggest misconceptions about FDA inspectors? I believe the biggest misconception about FDA inspectors is that they are there to “get you.” […]

We at FDAzilla are officially calling it. August is FDA Form 483s month. For the next 30 days, we will be posting a new article about FDA 483s every weekday – from insider insights to former investigator interviews to news synthesis to new data. As we’ve mentioned before, the FDA 483 is going through a […]

If you could ask the FDA anything about 483s or inspections anonymously, what would you ask? We’ve been in talks with the FDA, and it’s highly likely that they will be willing to answer a list of thoughtful questions from us. As the 483 has received increasing attention, it is in everyone’s best interest to […]

The first part of the month was relatively quiet, but then things really start hitting the fan last week.  Here are some of the latest stories related to FDA 483s: Of course, the big story of the month is Ranbaxy.  FiercePharma reported that it may have been a 483 that explains why Ranbaxy did […]