FDA 483 - Catalent Greenville Inc - July 12, 2019

An FDA inspection of Mayne Pharma Inc in Greenville, NC, revealed significant deficiencies in laboratory controls and quality system investigations. The firm failed to establish scientifically sound specifications and test procedures for environmental monitoring and water testing, and did not thoroughly review unexplained discrepancies or out-of-specification/out-of-trend results for drug products.