FDA Inspection 1102938 — Fenwal International, Inc.
The FDA completed an inspection of Fenwal International, Inc. on September 26, 2019 in Maricao, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 26, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Maricao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |