FDA 483 - MSI Express Inc - January 16, 2025

MSI Express Inc, a drug repacker in Newcomerstown, OH, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for failing to establish written procedures for Annual Product Review and for not documenting or investigating out-of-specification deviations. Additionally, batch production records were found to be deficient, lacking statements of actual and theoretical yield.