# FDA 483 - ALK-Abello, Inc. - May 03, 2021

Source: https://www.globalkeysolutions.net/records/483/alk-abello-inc/8ce8e894-4216-4266-9ef9-6d24167cfebd

> FDA 483 for ALK-Abello, Inc. on May 03, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALK-Abello, Inc.
- Inspection Date: 2021-05-03
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: This FDA Form 483 lists significant deficiencies at AllerQuest LLC in Plainville, CT, a drug manufacturer. The inspection revealed multiple issues related to aseptic processing, environmental monitoring, equipment cleaning, contamination control, and investigation of discrepancies, all impacting the quality and purity of PRE-PEN Injection Solution. The findings indicate a lack of adequate controls to prevent contamination and ensure product sterility.

## Related Documents

- [483 - 2019-03-01](https://www.globalkeysolutions.net/records/483/alk-abello-inc/0609b146-1f6d-4543-818a-1f9d5f84cd68)
- [483 - 2022-10-21](https://www.globalkeysolutions.net/records/483/alk-abello-inc/28026031-bf91-4f0d-80bc-dc0f6eb47d03)
- [483 - 2025-06-13](https://www.globalkeysolutions.net/records/483/alk-abello-inc/37e6bb23-c272-4afe-9175-6eb3395c8e4d)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7