FDA Inspection 1006378 — PDM Acondifarma, S.A. De C.V.
The FDA completed an inspection of PDM Acondifarma, S.A. De C.V. on Dec 2, 2016 in Ramos Arizpe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 2, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ramos Arizpe (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |