FDA 483 - McNeil Healthcare, LLC - March 31, 2021

McNeil Healthcare, LLC, an OTC drug product manufacturer in Las Piedras, Puerto Rico, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate control procedures for personnel qualification and defect identification, failures in thorough batch failure investigations and timely CAPA implementation, and deficiencies in equipment cleaning and maintenance. The firm also failed to follow written production procedures, ensure quality unit responsibilities were met, justify production time limit deviations, and maintain accurate calibration records.