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

Source: https://www.keypedia.com/records/483/alk-abello-inc/a1ed6004-f365-4339-a3f2-d3952c078a9c

> FDA 483 for Alk-abello, Inc. on October 17, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alk-abello, Inc.
- Inspection Date: 2023-10-17
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

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Company: https://www.keypedia.com/companies/alk-abello-inc/88a052a0-f653-45ca-a45e-89003e4e8565

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961