FDA 483 - PURETEK CORPORATION - October 24, 2024

PURETEK CORPORATION in Panorama City, CA, was issued a Form FDA 483 with two observations following an inspection from October 21-24, 2024. The firm failed to ensure equipment and utensils were cleaned at appropriate intervals, specifically by not validating cleaning for non-dedicated fillers and lacking data for clean/dirty hold times. Additionally, the company did not follow its own written cleaning procedures for filling equipment, leading to delayed cleaning of machinery used for both drug and dietary supplement products.