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 period of dramatically increased attention. More reporters are going directly to the 483 to source details of manufacturing and clinical woes. More hedge funds and investment banks have been calling us with detailed, educated questions about 483s – the intelligence they gather is incorporated into their investment/risk profiles. More law firms are obtaining 483s from us – I’ll let you guys figure out the rationale there. And of course, more manufacturers are obtaining 483s to do competitive intelligence, to qualify potential partners, and to glean inspector tendencies (sometimes, these inspectors are at their facility when they purchase 483s from us!).

For quite some time, the FDA was relatively forgiving when drug manufacturers slipped up in one area or another. Though inspectors might hand out Form 483s often, few in QA/RA/Compliance departments were particularly concerned.

Today, that era has long been over. The FDA is moving against erring manufacturers and research facilities faster and taking a tougher stance. Being cited more than once for a violation might have slipped by before, but today some companies might find matters quickly escalating from 483 to an official Warning Letter to a consent decree if they don’t watch themselves. Or a delayed product launch.

What’s more, the FDA has hired on hundreds of new inspectors, and these new inspectors are moving in with the zeal that you might expect from fresh recruits. What might have passed with a nudge-nudge, wink-wink isn’t going to fly any more, according to dozens of interviews conducted by FDAzilla researchers. While there’s no proof of this, some attorneys say the newer inspectors are actually competing to see who can find more violations.

In the following month, we’ll take your through insider perspectives, expert interviews, and new data related to 483s. We’ll also share the results of our exhaustive research on how to avoid 483s. The advice we got may not sound novel, but time and again, manufacturers are getting into trouble over the same issues, including:

  • Not documenting procedures and process adequately
  • Failing to produce that documentation, immediately, when inspectors ask for it
  • Letting plant maintenance slip (dripping pipes, doors that won’t close properly
  • Rusty walls
  • Not spending enough to train employees, and often, failing to document the
  • Training when they do invest
  • Getting sloppy about validation
  • Poor investigation of discrepancies or failures
  • Ignoring repeated warnings to fix the same violation

As you read, bear in mind one overarching principle, our experts say. It’s painfully obvious but comes up more than you think. If you do get a 483, respond promptly and fix the problem immediately and thoroughly. If you delay, the agency takes things very seriously.