FDA Inspection 920228 — Fenwal International, Inc.
The FDA completed an inspection of Fenwal International, Inc. on March 25, 2015 in Maricao, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 25, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maricao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |