# FDA 483 - ALS Group USA, Corp - January 25, 2019

Source: https://www.keypedia.com/records/483/als-group-usa-corp/0724040e-144f-4a1a-9490-c9fa043695b0

> FDA 483 for ALS Group USA, Corp on January 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALS Group USA, Corp
- Inspection Date: 2019-01-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of BioScreen Testing Services Inc in Torrance, CA, a control testing laboratory, revealed significant deficiencies in their quality system. Observations included a lack of software validation documentation, inadequate investigations into out-of-specification results and failures, incomplete laboratory records due to discarded original documentation, and failure to follow written production and process control procedures. These issues indicate a systemic breakdown in maintaining data integrity and ensuring product quality.

## Related Documents

- [483 - 2023-06-05](https://www.keypedia.com/records/483/als-group-usa-corp/7b63f612-3502-489d-bfad-d05724259da2)

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)
- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

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

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