In 2011 when serious manufacturing issues surfaced at the Ben Venue plant in Ohio, Pfizer ($PFE) decided to dump it as a supplier for its diluting agent for the cancer drug Torisel. In fact, Pfizer said it had an exit strategy for all of the drugs being made by the Boehringer Ingelheim unit. Now, a warning letter indicates the FDA is not so impressed with that part of the strategy involving the Torisel solution.
The warning letter, posted to the FDA website Tuesday, was delivered to Pfizer's Wyeth Lederle plant in Catania, Italy. It says the plant released a batch of the diluent without finding the cause of a number of repeated out-of-specification endotoxin results. The failures began on April 17, 2012, and the plant continued to test and retest samples from this lot through August 14, getting different results.
In fact, the plant went to quite an effort to find the root cause. It used different endotoxin testing platforms, tested at three different laboratories, and wiped external vials down with sanitizer. It still got inconsistent results. The agency was not impressed with the explanation that secondary packaging may have been at the root of the problem, saying the staff provided "no credible explanation" of how cardboard got into the samples.
The letter also criticized the facility for failing to meet the three-day deadline for notifying the agency about the possible contamination. "As mentioned above, your firm shipped a portion of Torisel Diluent batch AGMV/1 on Jan. 5, 2012, to a packaging facility, which then shipped (b)(4) vials of the batch to the United States on April 3, 2012. In your response to this letter, please explain why your firm failed to file the FAR [Field Alert Report] within the required timeframe and what actions your firm has taken to prevent recurrence."
The Ben Venue plant that Pfizer had been using recently signed a consent decree with the FDA, pledging to get on top of its issues. It, however, has been allowed to continue to manufacture about 100 products to avoid shortages of some essential treatments.
- here's the warning letter