FDA Inspection 1167929 — Eksa Mills S.A. De C.V.
The FDA completed an inspection of Eksa Mills S.A. De C.V. on Apr 19, 2022 in Heroica Puebla De Zaragoza. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 19, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Heroica Puebla De Zaragoza (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |