FDA Inspection
Uptite Company, Inc.Uptite Company, Inc. – FDA Inspection, Sep 1, 2015
Record Details
This FDA Inspection record concerns Uptite Company, Inc., with an inspection on September 1, 2015, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Uptite Company, Inc.
- Inspection Date
- September 1, 2015
- Product Type
- Veterinary
View Company Profile
ID · 007c6b96-40a6-4e49-b1d0-0ef5661199dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940505
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
11- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)(3)Identification of Components and In-Process Materials
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.100(a)Absence of Written Procedures
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Uptite Company, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 21, 2013 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 21, 2009 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Uptite Company, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.