Alk-abello, Inc.October 17, 2023

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

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Record Details

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.

Company: Alk-abello, Inc.
Inspection Date: October 17, 2023
Product Type: Biologics
Office: Division of Human and Animal Food Operations - East I
People: Hefziba Ricalde
Christian D. Lynch (investigator)
Shafiq S. Ahadi (Investigator)

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