# FDA 483 - ALK-Abello, Inc. - June 13, 2025

Source: https://www.keypedia.com/records/483/alk-abello-inc/37e6bb23-c272-4afe-9175-6eb3395c8e4d

> FDA 483 for ALK-Abello, Inc. on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALK-Abello, Inc.
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: New England District Office
- Summary: ALK-Abello, Inc. received a Form 483 following an inspection that revealed significant deficiencies in their aseptic processing operations. Key issues included inadequate validation of sterilization processes, deficient environmental monitoring, and failures in following established procedures for cleaning and contamination prevention. The observations highlight a lack of robust quality control and data integrity practices impacting the sterility assurance of their drug products.

## Related Documents

- [483 - 2019-03-01](https://www.keypedia.com/records/483/alk-abello-inc/0609b146-1f6d-4543-818a-1f9d5f84cd68)
- [483 - 2021-05-03](https://www.keypedia.com/records/483/alk-abello-inc/8ce8e894-4216-4266-9ef9-6d24167cfebd)
- [483 - 2022-10-21](https://www.keypedia.com/records/483/alk-abello-inc/28026031-bf91-4f0d-80bc-dc0f6eb47d03)

## Related Officers

- [Robin P. Mathew](https://www.keypedia.com/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.keypedia.com/companies/alk-abello-inc/b626f86d-b379-45aa-96d2-0661e9d1c981

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144