FDA Inspection 1251981 — NWL Netherlands Services B.V.
The FDA completed an inspection of NWL Netherlands Services B.V. on Oct 18, 2024 in Hillegom. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 18, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hillegom (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |