FDA Inspection
Uptite Company, Inc.Uptite Company, Inc. – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns Uptite Company, Inc., with an inspection on June 16, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · b5c2e2c4-3d75-4d0e-b3f8-62fba38431ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014373
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.68(a)Written calibration / inspection 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 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Uptite Company, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2015 | 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 |
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