FDA Inspection 864796 — Hyalynx Inc
The FDA completed an inspection of Hyalynx Inc on January 31, 2014 in Madisonville, KY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 31, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Madisonville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |