FDA Inspection 657587 — Vitrolife, Inc.
The FDA completed an inspection of Vitrolife, Inc. on April 16, 2010 in Englewood, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 16, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Englewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |