FDA Inspection 1181681 — Zermat Internacional, S.A. de C.V.
The FDA completed an inspection of Zermat Internacional, S.A. de C.V. on October 14, 2022 in Tlalnepantla. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 14, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tlalnepantla (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |