FDA Inspection 1180297 — Fenwal International, Inc.
The FDA completed an inspection of Fenwal International, Inc. on September 24, 2022 in Maricao, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 24, 2022
- Fiscal Year
- 2022
- 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 |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |