FDA Inspection
PDM Acondifarma, S.A. de C.V.PDM Acondifarma, S.A. de C.V. – FDA Inspection, Sep 15, 2022
Record Details
This FDA Inspection record concerns PDM Acondifarma, S.A. de C.V., with an inspection on September 15, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 15, 2022
- Product Type
- Drugs
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ID · 107c7008-9483-4c45-af44-a7ee687285fa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1181442
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
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Other FDA inspections of PDM Acondifarma, S.A. de C.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 21, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PDM Acondifarma, S.A. de C.V.
- FDA Inspection 1006378 - 2016-12-02
- FDA Inspection 571572 - 2009-01-21
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