FDA Inspection 1055383 — Laboratorios Baxter S.A.
The FDA completed an inspection of Laboratorios Baxter S.A. on Jun 8, 2018 in Cali. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 8, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cali (Colombia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |