It’s a lesson learned by children since time immemorial: Always clean your hands after taking out the trash. When dealing with sterile drugs, that lesson is even more important to follow—a rule a Tennessee compounding pharmacy has been reminded of the hard way.
FDA investigators cited Tennessee compounder Surgery Pharmacy Services for a host of cleanliness issues at its Chattanooga plant, including workers’ failure to change gloves after removing trash bins and to sanitize supplies carried between clean rooms, according to a warning letter posted online last week.
During an inspection between November and December 2019, FDA watchdogs observed Surgery employees removing trash in an aseptic clean room and then failing to change their gloves or sanitize their sleeves before returning to work.
One worker was seen “leaning into” an aseptic area without their forehead covered, and other employees failed to “disinfect supplies at each transition from areas of lower quality to areas of higher quality air,” the FDA found.
Inspectors further knocked Surgery for using a laminate work surface in one of its clean rooms that was “worn, stained, and chipped,” as well as using a nonsterile disinfectant to clean one of the rooms.
“There is a lack of assurance that your firm can aseptically produce drug products within your facility,” investigators wrote.
In all, the FDA judged Surgery’s plant to be “contaminated with filth” and recommended immediate corrective actions. In response to an earlier notice, Surgery said it would pump up its cleaning protocol—including buying a new work surface—but the FDA found their remediation plan lacking.