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FDA Inspection
•Uptite Company, Inc.•September 21, 2009

Uptite Company, Inc. – FDA Inspection, Sep 21, 2009

Record Details

This FDA Inspection record concerns Uptite Company, Inc., with an inspection on September 21, 2009, issued by the Center for Veterinary Medicine, covering veterinary.

Company
Uptite Company, Inc.
Inspection Date
September 21, 2009
Product Type
Veterinary
Office
Center for Veterinary Medicine
View Company Profile

ID · 8833f525-f834-4389-98cb-7561480979f4

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
613182
FDA center
Animal Drugs & Feeds
Project area
Monitoring of Marketed Animal Drugs, Feed, and Devices

FDA Citations

11
  1. 21 CFR 211.103Actual vs. theoretical yields not determined
  2. 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
  3. 21 CFR 211.188(b)(3)Identification of each component or in-process material
  4. 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
  5. 21 CFR 211.67(c)Cleaning/maintenance records not kept
  6. 21 CFR 211.165(a)Testing and release for distribution
  7. 21 CFR 211.84(d)(1)Identity Testing of Each Component
  8. 21 CFR 211.22(a)Lack of quality control unit
  9. 21 CFR 211.166(a)Lack of written stability program
  10. 21 CFR 211.52Washing and toilet facilities are deficient

Showing 10 of 11 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Uptite Company, Inc.

3
DateClassificationOfficeProject area
June 16, 2017VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
September 1, 2015VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
February 21, 2013VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
Other documents for Uptite Company, Inc.
  • FDA Inspection 1014373 - 2017-06-16
  • FDA Inspection 940505 - 2015-09-01
  • FDA Inspection 817792 - 2013-02-21

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