FDA Inspection
PDM Acondifarma, S.A. de C.V.PDM Acondifarma, S.A. de C.V. – FDA Inspection, Dec 2, 2016
Record Details
This FDA Inspection record concerns PDM Acondifarma, S.A. de C.V., with an inspection on December 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · baf5fe73-47c7-40d2-9459-1dba356d782c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006378
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.122(a)Written procedures describing in detail
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PDM Acondifarma, S.A. de C.V.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2022 | 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 1181442 - 2022-09-15
- FDA Inspection 571572 - 2009-01-21
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