FDA Inspection
ALS Czech Republic, S.R.O.ALS Czech Republic, S.R.O. – FDA Inspection, May 29, 2018
Record Details
This FDA Inspection record concerns ALS Czech Republic, S.R.O., with an inspection on May 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 478fe9aa-93a6-404a-8ef7-722dd25eb0b2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055382
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.194(a)Complete test data included in records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ALS Czech Republic, S.R.O.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 5, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ALS Czech Republic, S.R.O.
- FDA Inspection 1204802 - 2022-01-20
- FDA Inspection 833163 - 2013-05-22
- FDA Inspection 590376 - 2009-06-05
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