# FDA 483 - ALK-Abello, Inc. - October 21, 2022

Source: https://www.keypedia.com/records/483/alk-abello-inc/28026031-bf91-4f0d-80bc-dc0f6eb47d03

> FDA 483 for ALK-Abello, Inc. on October 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALK-Abello, Inc.
- Inspection Date: 2022-10-21
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: AllerQuest LLC, a drug manufacturer in Plainville, CT, was inspected by the FDA and received 11 observations. The inspection revealed significant deficiencies across aseptic processing, environmental monitoring, equipment design, component testing, laboratory controls, and quality system investigations. These issues indicate a high risk of contamination and product quality concerns for their sterile drug product, PRE-PEN Injection.

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

## Related Officers

- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)
- [Investigator](https://www.keypedia.com/people/edmund-f-mrak/a43cf86a-c020-4948-bff6-358b2453908a)

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