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In one extreme case, an FDA inspection concluded that Zorro Technology didn’t have written quality control procedures at all, that drug ingredients weren’t identified in terms of their status, and that batch records identifying the weight of compound quantities to be added weren’t present. Of late, inspectors are getting tougher about documentation requirements. In some […]

As you prepare for your next FDA inspections, bear in mind some of the key focus areas, which were high priorities for FDA inspectors in the last few years—all driven by patient safety concerns, according to a top pharma executive: Poor quality investigations of customer complaints, adverse events, significant deviations and out of specification results.Failure […]

When all is said and done, avoiding FDA 483s depends most heavily on the organization’s expectations and culture. Attention to quality has to permeate an entire organization from the top down and the bottom up, our panel said. Employees need to be motivated and incentivized to create products of the highest quality, and managers have […]

During weekends in August, FDA 483s month here at FDAzilla, we repost some of our favorite pieces related to 483s. Here’s a memorable story of an inspection in Costa Rica. The FDA had sent one of their best and toughest inspectors. The facility was located in Costa Rica. I had been sent there from the US […]

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, […]