FDA Inspection 613182 — Uptite Company, Inc.
The FDA completed an inspection of Uptite Company, Inc. on September 21, 2009 in Haverhill, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Haverhill, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |