FDA Inspection 1094297 — Hyalynx Inc
The FDA completed an inspection of Hyalynx Inc on June 27, 2019 in Madisonville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Madisonville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |