FDA Inspection 1223773 — Grupo Quimico SRL
The FDA completed an inspection of Grupo Quimico SRL on November 22, 2023 in Montevideo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 22, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Montevideo (Uruguay)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 2397 | 21 CFR 211.194(a)(1) | Description and Identification of Samples |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |