FDA Inspection
ALS Group USA, CorpALS Group USA, Corp – FDA Inspection, Jan 25, 2019
Record Details
This FDA Inspection record concerns ALS Group USA, Corp, with an inspection on January 25, 2019, issued by the Los Angeles District Office, covering human drugs.
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ID · 877484d8-0afd-4c3e-ba4d-bf0238f90290
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077330
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.68(b)Written record not kept of program and validation data
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Other FDA inspections of ALS Group USA, Corp
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2026 | VAI | Los Angeles District Office | Drug Quality Assurance |
| June 5, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1334830 - 2026-09-04
- FDA Inspection 1207264 - 2023-06-05
- FDA Inspection 1041299 - 2018-02-16
- FDA Inspection 883899 - 2014-06-18
- FDA Inspection 770574 - 2012-03-01
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