FDA Inspection 760626 — Vitalife, Inc.
The FDA completed an inspection of Vitalife, Inc. on Dec 28, 2011 in San Juan, 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 28, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |