FDA Inspection
Laboratorios Cosmodent SLLaboratorios Cosmodent SL – FDA Inspection, Jun 9, 2017
Record Details
This FDA Inspection record concerns Laboratorios Cosmodent SL, with an inspection on June 9, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · db826751-57ca-4450-bf92-20f77f691ce9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014292
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.130(e)Packaging line inspection after use
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of Laboratorios Cosmodent SL
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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