FDA Inspection 1205610 — HP Halden Pharma AS
The FDA completed an inspection of HP Halden Pharma AS on May 10, 2023 in Halden. 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
- May 10, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Halden (Norway)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |