FDA Inspection 769057 — Fenwal International, Inc.
The FDA completed an inspection of Fenwal International, Inc. on Feb 24, 2012 in Maricao, PR. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 24, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maricao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 8906 | 21 CFR 314.81(b)(1)(i) | Mix-up |