FDA Inspection 552589 — Cylex, Inc.
The FDA completed an inspection of Cylex, Inc. on Dec 17, 2008 in Columbia, MD. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Columbia, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2601 | 21 CFR 820.30(d) | Essential design outputs |
| 2649 | 21 CFR 820.30(f) | Design verification acceptance criteria |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3673 | 21 CFR 820.30(c) | Design input approval documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |