USAntibiotics LLC – FDA 483, Apr 4, 2025

USAntibiotics LLC in Bristol, TN, received a Form FDA 483 following an inspection from March 31 to April 4, 2025. The inspection revealed significant deficiencies in quality control, including failure to test every product lot for microbiological specifications prior to release, inadequate investigation of out-of-specification laboratory results, and a lack of written procedures for handling suspect or illegitimate products under the DSCSA. These observations indicate a need for improved adherence to good manufacturing practices and supply chain security regulations.