FDA 483 - Alk-abello, Inc. - October 17, 2023

During an inspection of Alk-abello, Inc. in Port Washington, NY, the FDA observed issues with the firm's investigation records. Specifically, investigations into unexplained discrepancies, such as false negative skin test results for peanut allergies, lacked conclusive findings and follow-up studies. This indicates a deficiency in the firm's quality system regarding complaint investigations and root cause analysis.