FDA Inspection 852965 — Algostream, Inc.
The FDA completed an inspection of Algostream, Inc. on October 25, 2013 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). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2013
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Orange City, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4576 | 21 CFR 211.192 | No written record of investigation |