FDA 483 - Spray-Tek LLC - August 17, 2022

Spray-Tek, LLC, a contract manufacturer in Bethlehem, PA, was inspected and cited for failing to adequately investigate environmental monitoring excursions. The firm did not identify root causes or corrective actions, conduct product impact risk assessments, or evaluate these findings prior to releasing affected batches. This indicates significant deficiencies in their quality control and investigation processes.