Unipharm Inc. – FDA 483, Oct 5, 2022

Unipharm Inc., a drug product packager and repacker in Waterbury, CT, received a Form 483 with four observations related to significant deficiencies in their manufacturing and quality control processes. The issues include inadequate packaging process validation, unsuitable equipment design, unwritten quality control procedures, and insufficient cleaning validation for non-dedicated equipment, indicating a lack of robust controls for drug product quality and safety.