FDA Inspection 1052824 — Baxter Hospitalar Ltda
The FDA completed an inspection of Baxter Hospitalar Ltda on May 18, 2018 in Sao Paulo. 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
- May 18, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sao Paulo (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |