# FDA 483 - Regis Technologies, Inc. - November 16, 2022

Source: https://www.globalkeysolutions.net/records/483/regis-technologies-inc/6de1b7f6-ab85-4578-8d83-6e955401ace2

> FDA 483 for Regis Technologies, Inc. on November 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regis Technologies, Inc.
- Inspection Date: 2022-11-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: Regis Technologies, Inc. in Morton Grove, IL, a drug substance manufacturer, received a Form 483 with two observations. The inspection revealed significant failures within the Quality Unit, including a failure to investigate temperature excursions and lack of documentation from their validated Data Acquisition System during Active Pharmaceutical Ingredient manufacturing. Additionally, the firm failed to properly label rejected materials, indicating a lapse in material control procedures.

## Related Officers

- [Enrico Mangahis](https://www.globalkeysolutions.net/people/enrico-mangahis/372a40e1-2525-435b-a295-27cb5d75a763)
- [Nibin Varghese](https://www.globalkeysolutions.net/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.globalkeysolutions.net/companies/regis-technologies-inc/b28a19bd-2caa-4023-9b89-ee609c032939

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766