FDA 483 - PEL Healthcare LLC - January 13, 2023

PEL Healthcare LLC, a drug product manufacturer in Sellersville, PA, was cited for significant deficiencies in its quality system and laboratory controls during an FDA inspection. Observations included a failure to thoroughly investigate unexplained discrepancies and out-of-specification results, as well as inadequate laboratory control procedures for chromatographic analyses and equipment calibration. These issues raise concerns about the scientific soundness and reliability of product release testing.