FDA Inspection
ALS Group USA, CorpALS Group USA, Corp – FDA Inspection, Sep 4, 2026
Record Details
This FDA Inspection record concerns ALS Group USA, Corp, with an inspection on September 4, 2026, issued by the Los Angeles District Office, covering human drugs.
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ID · 25be673d-1844-482e-9bc6-dfb3390de0b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1334830
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of ALS Group USA, Corp
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2019 | VAI | Los Angeles District Office | Generic Drug Evaluation |
| February 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 1, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ALS Group USA, Corp
- FDA Inspection 1207264 - 2023-06-05
- FDA Inspection 1077330 - 2019-01-25
- FDA Inspection 1041299 - 2018-02-16
- FDA Inspection 883899 - 2014-06-18
- FDA Inspection 770574 - 2012-03-01
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