FDA Inspection 987522 — Algostream, Inc.
The FDA completed an inspection of Algostream, Inc. on August 12, 2016 in Orange City, IA. 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
- August 12, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Orange City, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |