FDA Inspection 966842 — Lacrimedics Inc
The FDA completed an inspection of Lacrimedics Inc on March 15, 2016 in Dupont, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 15, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dupont, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |