FDA 483 - Plastikon Healthcare LLC - November 04, 2021

An FDA inspection of Plastikon Healthcare LLC in Lawrence, KS, revealed 11 observations concerning significant deficiencies in their drug manufacturing operations. The firm failed to ensure proper component testing, maintain microbial control, thoroughly investigate out-of-specification results, and implement adequate data integrity and quality control procedures. These issues indicate a broad lack of adherence to good manufacturing practices for their over-the-counter drug products.