Device makers are by now quite aware that FDA-inspected firms have 15 working days to respond to an inspectional form 483, but is this always consistently applied? It would appear not. Whether that difference makes a difference in the issuance of warning letters is tough to know, but one might think there are reasons for misgivings.
An example of when FDA is lenient (and I assure the reader this is not the only such case) is the Dec. 9, 2014, warning letter to Customed of Puerto Rico, for an inspection that ran July 14-31. Customed responded first within the 15 working day time frame with an Aug. 21 response, but FDA also considered a Sept. 8 "response update" in its consideration of the company's efforts to come into compliance.
Conversely, FDA did not allow a response beyond 15 days in the November 2014 warning letter to Stanmore Implants of Elstree, UK. The inspection took place July 28-31 last year, and FDA indicated that the company had inked three responses. The first of these was dated Aug. 21, which would have just made the 15-day turn-around mandate.
Stanmore replied twice more, on Sept. 26 and Oct. 15, which the agency declined to consider in its response to the company. It's obviously impossible to know whether consideration of those responses would have changed the outcome without filing a FOIA request for those documents, but they certainly could not have hurt the company's chances of avoiding a warning letter, not to mention the detention FDA slapped on the company's products.
One obvious question is: When is a second response a "response update" and when is it not?
But let's also ask about the justification for the differential treatment. Is it at the discretion of the issuing office? The Stanmore letter came from the Office of Compliance, which may feel it has to be a stickler for this sort of thing, whereas the Customed warning letter came, not unexpectedly, from the San Juan district office.
Whatever the explanation, a bit of disclosure might be appropriate here. I'm not necessarily arguing for a formal policy, but these warning letters – which are intended as public statements as David Kessler made clear back when he implemented the warning letter program more than 20 years ago – might be a good place for an explanation as to why the 15-day deadline is or is not observed.
Detention issue resurfaces?
We all remember the controversy that erupted in 2001 when regulatory attorney Larry Pilot challenged then-CDRH director David Feigel on the issue of whether detention was unfairly applied to non-U.S. companies. Pilot intimated that U.S. device makers were less likely to have to deal with a quarantine of their offerings, and the Stanmore warning letter would seem to bring that issue back up.
The reason I ask is that I could not find any indication that the devices in question had been recalled, although FDA said there had been a couple of instances of implant device malfunctions. I'm not sure that a handful of device malfunctions is all that conspicuous, though, given the absence of a denominator.
Beyond that, the Stanmore letter dealt largely with documentation issues, which often make up the entirety of a warning letter bill of fare, so there's no answer to be found there. Maybe we should ask Pilot and Feigel.