First and foremost, we agree that patients need to come first. We absolutely understand and respect that, and that's why we're doing our part in this time of crisis. We are not hiding behind our role, our jurisdiction, and we have taken extraordinary measures to expedite review processes to approve drugs through the special access program. However, as the member pointed out, all parties need to step up and do their part if we're going to be able to deal with these shortages. We continue to believe that we play a unique role, as do other parts of the health system, and we must all step up equally to respond to this challenge.
With respect to the November warning letter that was issued by the FDA, there are a couple of elements that are important for the committee to clearly understand. The FDA issued its warning letter. That was made publicly available. We saw it on the FDA's website in December. That was a warning letter. There was a deficiency, and it asked Sandoz to respond to that deficiency. It did not close the plant. It was not specific to Sandoz Boucherville; there are two sites in the U.S. It was a warning letter that did reference Sandoz but also included other sites in the United States.
It's also important to note that Health Canada had been in and inspected the Sandoz plant. As with the FDA, we had observations with respect to our inspection and had written to the company asking them to follow up with us as well. At no point were we aware that there would be a shortage, the crisis that we are facing today.
We followed up with Sandoz through the months of November, December, and January to understand how they would be responding to both our observations as a regulator in Canada and in regard to what they would be doing in response to the FDA. We were not fully aware of the full extent to which Sandoz would be dealing with this until they publicly wrote to all of their clients.