FDA Inspection 1045390 — Jabones Y Productos Especializados SA de CV
The FDA completed an inspection of Jabones Y Productos Especializados SA de CV on March 23, 2018 in Guadalajara. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guadalajara (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |