The FDA has updated its narrative account of the PCA crisis to focus on the recall from the Plainview, TX plant, including the following:
The Texas DSHS is currently notifying all first-level customers of PCA Texas products from January 1, 2007 forward that all products are subject to recall. FDA will audit 100 percent of those PCA customers to facilitate the removal of product from the marketplace.
There are several recall notices already posted on the FDA website, and many more press releases out on the web that haven't been posted to the FDA site.
Few have noted that the FDA field staff which is carrying out these recall audits is exactly the same staff responsible for routine inspections and other investigations. State inspectors are also contributing to the follow-up work, based on a couple of conversations I've had with field inspectors.
This is a vicious cycle -- the underfunded and overworked field staff is unable to conduct routine work in a way that might prevent a recall of this size, so the recall happens, pulling that staff for weeks on end away from routine work, so....
Meanwhile, the political classes and editorial writers yammer on and on about federal level reorganizations and a laundry list of other fairly useless "reforms."
Time for an FDA field staff surge. We can worry about rest later.