FDA Inspection 898343 — GE Healthcare Ireland Limited
The FDA completed an inspection of GE Healthcare Ireland Limited on Sep 15, 2014 in Carrigtwohill. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 15, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carrigtwohill (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |