FDA Inspection 1181442 — PDM Acondifarma, S.A. De C.V.
The FDA completed an inspection of PDM Acondifarma, S.A. De C.V. on Sep 15, 2022 in Ramos Arizpe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 15, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ramos Arizpe (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |