FDA Inspection 1294942 — Fenwal International, Inc.
The FDA completed an inspection of Fenwal International, Inc. on February 5, 2026 in Maricao, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 5, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Maricao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |