FDA Inspection 1023083 — Cytophil, Inc.
The FDA completed an inspection of Cytophil, Inc. on August 23, 2017 in East Troy, WI. 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
- August 23, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- East Troy, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |