FDA Inspection
Laboratorios Cosmodent SLLaboratorios Cosmodent SL – FDA Inspection, Sep 2, 2022
Record Details
This FDA Inspection record concerns Laboratorios Cosmodent SL, with an inspection on September 2, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratorios Cosmodent SL
- Inspection Date
- September 2, 2022
- Product Type
- Drugs
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ID · adaa0bff-dd9f-462e-8773-5e8451200672
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1178764
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Laboratorios Cosmodent SL
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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