FDA Inspection
Laboratorios Sophia, S.A. De C.V.Laboratorios Sophia, S.A. De C.V. – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Laboratorios Sophia, S.A. De C.V., with an inspection on December 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f0eb8e09-f1b9-49dd-9932-4bf08915fb4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075932
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 111.105(b)Quality control - supplier qualification
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Other FDA inspections of Laboratorios Sophia, S.A. De C.V.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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