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FDA Inspection
•K Klean dba West Agro•June 25, 2010

K Klean dba West Agro – FDA Inspection, Jun 25, 2010

Record Details

This FDA Inspection record concerns K Klean dba West Agro, with an inspection on June 25, 2010, issued by the Center for Veterinary Medicine, covering veterinary.

Company
K Klean dba West Agro
Inspection Date
June 25, 2010
Product Type
Veterinary
Office
Center for Veterinary Medicine
View Company Profile

ID · db258f77-8756-4118-a782-5b30bd462bce

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
668133
FDA center
Animal Drugs & Feeds
Project area
Monitoring of Marketed Animal Drugs, Feed, and Devices

FDA Citations

6
  1. 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
  2. 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
  3. 21 CFR 211.22(c)Approve or reject procedures or specs
  4. 21 CFR 211.100(a)Absence of Written Procedures
  5. 21 CFR 211.67(b)Written procedures not established/followed
  6. 21 CFR 211.80(a)Written Procedures Not Followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of K Klean dba West Agro

4
DateClassificationOfficeProject area
March 15, 2019VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
September 19, 2017VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
December 16, 2014NAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
February 14, 2012VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
Other documents for K Klean dba West Agro
  • FDA Inspection 1082970 - 2019-03-15
  • FDA Inspection 1025835 - 2017-09-19
  • FDA Inspection 909930 - 2014-12-16
  • FDA Inspection 767675 - 2012-02-14

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