# FDA 483 - ALS Group USA, Corp - June 05, 2023

Source: https://www.globalkeysolutions.net/records/483/als-group-usa-corp/7b63f612-3502-489d-bfad-d05724259da2

> FDA 483 for ALS Group USA, Corp on June 05, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALS Group USA, Corp
- Inspection Date: 2023-06-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of ALS Group USA, Corp in Torrance, CA, a contract testing laboratory, from May 31 to June 5, 2023, identified one significant observation. The firm was cited for using equipment for preparing and sterilizing microbiological media for drug product testing beyond its scheduled requalification date. This indicates a failure to maintain equipment in a qualified state for its intended use.

## Related Documents

- [483 - 2019-01-25](https://www.globalkeysolutions.net/records/483/als-group-usa-corp/0724040e-144f-4a1a-9490-c9fa043695b0)

## Related Officers

- [Youkeun Kim](https://www.globalkeysolutions.net/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/tiara-m-brown/bbc93754-69de-4379-b9f5-f85ea4c8b0e9)

Company: https://www.globalkeysolutions.net/companies/als-group-usa-corp/6d3305d4-76a4-4d57-8ed6-1e636d486309

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6