Loading…
Exela Pharma Sciences, LLC, a drug manufacturer in Lenoir, North Carolina, violated Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection conducted in November 2024. The company failed to thoroughly investigate unexplained discrepancies and failures in batch specifications, specifically invalidating failing growth promotion results without adequate root cause investigations—results that are critical for determining the suitability of media used in sterility testing of finished drug products. These violations rendered the company's drug products adulterated under federal law, as their manufacturing methods, facilities, and controls did not conform to CGMP standards for finished pharmaceuticals.