There’s trouble brewing in the Chicago suburbs, where the FDA has served up another round of warnings to a pharmaceutical laboratory using its space to craft small-batch beer.
A recent inspection of Pharmaceutical Laboratories and Consultants Inc., in Addison, Ill., found brewery supplies casually mixed in with equipment used to evaluate over-the-counter drug products. In one instance, the facility had stored a beer fermenter and created a workspace for a brewery employee preparing kegs, all within 10 feet of an area where microbiological material is kept.
“In addition, laboratory test media, open beer bottles, and brewing materials were co-mingled within the same refrigerator,” the FDA wrote in a warning letter sent on Sept. 13.
The dual-use facility poses “unacceptable risks,” the agency said, including the contamination of materials used to test over-the-counter drug products.
For this particular facility, it is not a new phenomenon. The FDA, in its recent letter, said it had also discovered similar violations during inspections in 2007, 2009, 2012, and 2014.
“Conducting your testing operations in a space shared with a microbrewery is inappropriate and does not comply with [manufacturing guidelines],” the FDA wrote.
It wasn’t just the beer, either — the FDA also expressed concern that the facility lacked data to show its testing procedures were scientifically sound, and that it had inadequate test methods to detect numerous microorganisms that could contaminate pharmaceutical products.
James Stephen, listed by the FDA as the facility’s president and owner, could not immediately be reached for comment.
The facility’s Facebook page provides little detail about its operations and no hint of its secondary use. It does, however, promise “info on FDA warning letters, validation tips and other regulatory news” — though the last post on the page is from April 2012.
The FDA has left time for a hoppy ending, giving the facility 15 days to mount a stout defense in a written response detailing its steps for improving safety and cleanliness.