FDA Inspection 1100537 — GE Healthcare AS
The FDA completed an inspection of GE Healthcare AS on August 27, 2019 in Oslo. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oslo (Norway)
Citations
| ID | CFR | Description |
|---|---|---|
| 17813 | 21 CFR 212.50(a) | Written control procedures |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |