A suppository maker that has been a problem for the FDA in the past is at it again. An inspection of its New Jersey manufacturing facility found its equipment was “filthy” and some of it held together with tape and plastic wrap.
On top of that, the warning letter for Acino Products, an over-the-counter maker of suppositories and topical solutions, said it could not come up with documents for microbiological testing.
While the company pledged to make fixes and improvements, the FDA said it was not nearly enough. Instead, the FDA ordered the company to provide a comprehensive, independent assessment of its laboratory practices and a plan to upgrade its cleaning and testing procedures. It also suggested Acino hire a consultant to help.
The letter noted that during the May 2019 visit at the Hamilton, New Jersey, plant, an inspector saw dislodged and missing ceiling tiles directly above its mixing tank, open hopper and filling machine while it was manufacturing bisacodyl suppositories.
It also found equipment it said was “filthy and covered with residue” and reported the drugmaker couldn’t provide data to show validated procedures for cleaning the equipment.
A suppository filling machine had a device for maintaining a constant temperature attached “with tape and plastic wrap,” and Acino couldn’t assure the FDA that it could reach or maintain the appropriate temperature.
The cleaning issues, the letter says, are repeats from an earlier inspection. The sanitation problems had been raised during a visit in 2017.
FDA concerns with Acino track back further than that. In fact, in 2015, the FDA got a permanent injunction against the company after it continued to sell suppositories the FDA said had never been evaluated and approved.