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FDA Form 483 Warning Letter - What next?


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I your FDA 483 response is not adequate, you will receive Warning Letter.

If your Warning Letter response is not adequate, what happens? Does the FDA comes visit your facilities and shut down manufacturing or do they just ban your device(s) from US markets?


Based on my own experience, the question isn't only what steps the FDA will take against the company. An important factor in how these issues resolve is in how your company addresses them internally. Does the company take the observations seriously and make a firm effort to address them or does it simply try to defend it's existing practice?

The company I work at initially responded to a 483 by sticking by their existing practices. Rather than correcting the issues they simply blamed the inspector. Naturally this was a bad idea. Eventually our internal thinking changed and true efforts to address the observations were taken. Unfortunately, the culture hasn't changed. An evironment still exists in which all other departments feel empowered to challenge each and ever Quality Assurance decision.

Ronen E

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I your FDA 483 response is not adequate, you will receive Warning Letter.

If your Warning Letter response is not adequate, what happens? Does the FDA comes visit your facilities and shut down manufacturing or do they just ban your device(s) from US markets?

FDA doesn't have jurisdiction to "shut down manufacturing" outside the USA. They may ask to visit your premises (I don't think that is a likely step following an inadequate response to a warning letter), and they may very well ban your products from entry into the USA, as well as a host of other sanctions (that could involve other USA authorities as well - they explicitly say that in warning letters). they may also share their findings and actions with regulatory authorities in countries other than the USA, which may then take their own steps... Best to avoid this situation.

Anyone know if the FDA has any specified timelines with respect to their review of responses to warning letters & resolutions?

A quick look at the FDA Warning Letters page shows there are a ton of unresolved warnings dating back for years...

Furthermore, many that are resolved show dates spanning years between issuance and resolution.

Not sure if this reflects:
a) a backlog of paperwork (wouldn't surprise me)
b) lack of updates to the webpage (wouldn't surprise me either)
c) that most of these company's responses to date are inadequate and hence the files are still unresolved


During the period between Warning Letter issuance and close-out, the subject company is in a heightened-oversight situation. Multiple short-notice or no-notice FDA inspections may occur. FDA may do a lot of "fishing" through records, and camp out at the company. This can go on for a long time if FDA thinks the subject company is sufficiently important to justify the focus.

A major global OEM's medical imaging equipment operation got a warning letter several years ago for poor control practices in software development among other problems. They were on shipment hold for something like two years and were inspected, IIRC, five times before FDA finally granted them a close-out.

It made quite a difference to that division's operations and profit contribution. Their line of US made equipment essentially was terminated due to reputation damage and operational disruption.
So, in otherwords, there is no time-frame...? Companies can potentially just leave their status unresolved and stay in the "heightened-oversight situation" indefinitely?

Given the sheer number of unresolved warnings spanning years, I guess this might be the case for some of them...

I can't help but think that in most cases, however, it might be largely a backlog on the FDA side... I can only imagine that for some companies, their responses are hundreds or even thousands of pages... and given the FDA's reputation for scrutiny, that's a lot of paper to (finely) comb over. Not to mention all the new cases pouring in...


Certainly in the case of the imaging equipment company I referenced, it did take the FDA a long time to evaluate their catch-up design control work. As I understand, they were required to retroactively design-control and document all of the design-related activity for which FDA was not satisfied as to records, that had occurred over a number of years.

In some cases, a warning letter is associated with an FDA-required field action. In those instances, FDA also won't issue a closeout until the field action reaches an FDA-determined success threshold. For a field action extending back years, it can be very difficult and expensive to find units in the field and convince customers to cooperate, and/or to document in an FDA-satisfactory manner that units have been used, discarded or otherwise are no longer available. In instances where units have been used, FDA sometimes has required that documentation be provided that proper medical review was provided to each individual patient involved at no cost to them, to assure that their involvement with the recalled device had no unreported adverse effects.

Inability to get to the FDA-required recall threshold was one of the factors in the referenced medical imaging company situation, I think.
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