940505
Uptite Company, Inc. — FEI 1219320
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 1, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Haverhill, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2015 | 21 CFR 211.188(b)(3) | Identification of Components and In-Process Materials |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |