FDA 483 - Arkema, Inc. - September 22, 2021

Arkema, Inc. in Piffard, NY, an API manufacturer, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate cleaning validation practices, failing to conduct trace analysis or challenge hard-to-clean areas, and relying solely on visual inspection. Additionally, the inspection revealed deficiencies in annual product review procedures, which did not include a review of complaint and investigation records, and a failure to establish and follow written procedures for the quality control unit's complaint handling, leading to inconsistent and delayed investigations.