A regulatory inspection conducted from September 18 to October 10, 2018, in Addison, Illinois, prompted the US Food and Drug Administration (FDA) warning letter.
According to the agency, the inspection uncovered a microbrewery operating in space shared with over-the-counter drug testing activities and media storage areas.
“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,” wrote the Agency.
“In addition, laboratory test media, open beer bottles, brewing materials were co-mingled within the same refrigerator,” the US FDA added.
Other current good manufacturing practice (cGMP) violations cited include unsuitable media practices for the testing of over-the-counter (OTC) products and components.
“Our investigators observed that you did not have any microorganisms stored at your facility and did not have the test strains and specified microorganisms for completing microbiological testing,” according to the FDA.
In addition, agency investigators “observed dried and cracked test plates in your incubators. Their condition would prevent detection of microorganisms present in the product.”
Data concerns
In the warning letter, the FDA highlighted concerns Pharmaceutical Laboratories and Consultants had not followed data protocol, and in particular had recorded results for tests that were not conducted.
“Your firm also failed to document critical information on microbiological worksheets [and]…neglected to record incubation times, laboratory materials, and equipment numbers for sample preparation,” noted the agency.
This latest inspection is the not the first to reveal cGMP deviations for the contract testing firm. According to the FDA, a number of inspections between 2007 and 2014 exposed Pharmaceutical Laboratories and Consultants’ failure to comply with cGMP – including an inspection that resulted in a warning letter issued on July 25, 2007.
