FDA Inspection
Berioska SLBerioska SL – FDA Inspection, May 3, 2024
Record Details
This FDA Inspection record concerns Berioska SL, with an inspection on May 3, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9e577c3c-2182-43ba-a5ef-4692cbfedfad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1238041
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.84(d)(2)Component identification test
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