FDA Inspection 1203534 — Fenwal International, Inc.
The FDA completed an inspection of Fenwal International, Inc. on Apr 25, 2023 in Bajos De Haina. 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 25, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bajos De Haina (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |