FDA Inspection 1003170 — PROSANA DISTRIBUCIONES SA DE CV
The FDA completed an inspection of PROSANA DISTRIBUCIONES SA DE CV on Mar 9, 2017 in Ciudad De Mexico. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 9, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ciudad De Mexico (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |