FDA Cites Pharmaceutical Plant for Sanitation Violations in Cleanrooms

Staff maintaining cleanrooms follow strict protocols to keep these areas sterile. Cleanrooms are specifically designed with controlled environments that keep contaminants out and are found in various industries from aerospace to pharmaceutical manufacturing. Facilities that don’t follow strict cleanroom procedures can receive citations from the U.S. Food and Drug Administration (FDA).

The FDA cited Surgery Pharmacy Services, a compounding pharmacy, for sanitation issues in its cleanrooms, reports Fierce Pharma.

According to a warning letter posted online last month, FDA investigators cited Surgery Pharmacy Services’ Chattanooga, Tennessee plant for its employees’ failure to change gloves and sanitize their sleeves after removing trash bins in an aseptic clean room. Investigators also found workers were not sanitizing supplies carried between cleanrooms, putting the areas at risk of cross-contamination.

In addition, FDA inspectors saw employees “using a laminate work surface in one of Surgery’s clean rooms that was ‘worn, stained, and chipped,’ as well as using a nonsterile disinfectant to clean one of the rooms,” according to Fierce Pharma.

Although officials at Surgery Pharmacy Services said they would improve their cleaning practices and purchase new work surfaces, investigators found the plan lacking and question whether the facility can aseptically produce drug products. The FDA recommends immediate corrective actions.

CMM provides an infographic detailing cleanroom requirements and classifications.