Shared Space with Non-Drug OperationsWhat's wrong with mixing business and pleasure? (Answer: lots, in this case.)
In addition, our inspection revealed that you were operating a microbrewery in space shared with your contract testing laboratory where you test OTC drug products and components. You prepared and stored microbiology laboratory media in the same area you use to conduct brewery operations.
For example, our investigators observed a full fermenter located approximately ten feet from the space where media is prepared, warmed, and stored. A brewery employee was also preparing beer kegs in this area. In addition, laboratory test media, open beer bottles, and brewing materials were co-mingled within the same refrigerator.
These facility conditions pose unacceptable risks, including contamination of media during its preparation and compromised sample analyses. Conducting your testing operations in a space shared with a microbrewery is inappropriate and does not comply with CGMP. Your testing must be performed using facilities that are designed and controlled for drug laboratory testing.
Wednesday, September 26, 2018
Warning Letter of the Week: It's 5 o'clock somewhere edition
Via a missive to the President and Owner of Pharmaceutical Laboratories and Consultants, Inc. in Addison, IL, a certainly unusual comment: