A 483 is the vernacular for an FDA inspection of quality standards, manufacturing or the conduct of a clinical trial, and the discovery of deficiencies therein. In other words, theygo through your manufacturing facility, for example, and then write up a list of the deficiencies and submit it to the company. A company does not have to respond to the FDA in writing. But, according to a presentation made by FDA in January, there are good reasons to do so.
Anything that is named by a number of a form – in this case Form 483 – sounds really bureaucratic and uninteresting. Well, this is the exception to that rule. A Form 483, if serious enough or left improperly attended can lead to a Warning Letter, or even worse in some circumstances – to a Consent Decree. Large pharmaceutical companies, manufacturers and even non-profits have faced the prospect of Consent Decrees. That is why a 483 is a big deal, not only from a substantive point of view – but from a communications point of view as well.
In January 2009, the FDA presented "Writing an Effective 483 Response" at a conference held in Las Vegas. It has some excellent advice, which bears echoing. The presentation gave four reasons for submitting a response:
(i) A response could mitigate further FDA regulatory actions; (ii) A response demonstrates to the FDA and other stakeholders that the company understands the issues; (iii) A response demonstrates a commitment and intent to comply; and (iv) A response helps to establish credibility with FDA. I would add a fifth and that is that the company is forced to analyze and agree on language that will characterize the situation – i.e., messaging.
The presentation goes on to provide insight into elements that should be considered in developing a response:
- Include a statement and commitment from senior leadership;
- Address each observation separately;
- Note whether you agree or disagree with each observation;
- Provide a corrective outline that is specific, comprehensive, addresses the issues and is one that can be realistically delivered;
- Provide a timeframe;
- Commit to transparency and confirmation by credible parties;
- Submit appropriate documentation
- Be timely.
That is not only a guideline for response to 483s, it is a good outline for response to any crisis.