FDA 483 - Athenex Pharma Solutions, LLC - September 16, 2022

The FDA Form 483 documents a failure to thoroughly review batch failures, specifically regarding sterility failures of finished products. The facility's investigations into sterility failures were not comprehensive enough to identify root causes or implement robust corrective and preventative actions.

Between October and December 2021, two sterility failures were observed in finished product sterility testing, identifying Gram Positive Rods (Bacillus licheniformis and Niallia circulans), belonging to the Bacillus species family. These failures were investigated under #OOS-007-2021-0044 for 8mg Norepinephrine in 0.9% Sodium Chloride (250mL IV Bag), Lot# (b)(4), and #OOS-007-2021-0054 for 1 Unit/mL Vasopressin 0.9% Sodium Chloride (50mL), Lot# (b)(4).

The investigations were deficient as they did not include comprehensive evaluations of environmental monitoring results from the compounding area and personnel. Furthermore, the review of environmental results did not extend to all excursions from all sources during the relevant period. The facility failed to identify elevated environmental excursions in the aseptic processing area, such as viable air monitoring samples, as a potential contamination source. Consequently, adequate corrective actions were not implemented to mitigate spore-forming microorganisms in the environment and protect product sterility during aseptic operations.

Specifically, the environmental trend report for (b)(4)