# FDA 483 - ALK-Abello, Inc. - March 01, 2019

Source: https://www.keypedia.com/records/483/alk-abello-inc/0609b146-1f6d-4543-818a-1f9d5f84cd68

> FDA 483 for ALK-Abello, Inc. on March 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALK-Abello, Inc.
- Inspection Date: 2019-03-01
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of AllerQuest LLC, a sterile human drug manufacturer in Plainville, CT, revealed significant deficiencies across multiple critical areas. The firm was cited for inadequate aseptic processing controls, environmental monitoring, and a failure to thoroughly investigate discrepancies and critical defects. Repeat observations from previous inspections highlight persistent issues with quality unit oversight, cleaning validation, and process validation, indicating a systemic lack of control over sterile drug product manufacturing.

## Related Documents

- [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)
- [483 - 2025-06-13](https://www.keypedia.com/records/483/alk-abello-inc/37e6bb23-c272-4afe-9175-6eb3395c8e4d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Jonah S Offerjost](https://www.keypedia.com/people/jonah-s-offerjost/66afe9d0-ba7f-467d-b7bf-a83cc02b1d1e)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94