FDA 483 - ALK-Abello, Inc. - May 03, 2021

This FDA Form 483 lists significant deficiencies at AllerQuest LLC in Plainville, CT, a drug manufacturer. The inspection revealed multiple issues related to aseptic processing, environmental monitoring, equipment cleaning, contamination control, and investigation of discrepancies, all impacting the quality and purity of PRE-PEN Injection Solution. The findings indicate a lack of adequate controls to prevent contamination and ensure product sterility.