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FDA Inspection
•GEA Farm Technologies Inc•May 31, 2019

GEA Farm Technologies Inc – FDA Inspection, May 31, 2019

Record Details

This FDA Inspection record concerns GEA Farm Technologies Inc, with an inspection on May 31, 2019, issued by the Center for Veterinary Medicine, covering veterinary.

Company
GEA Farm Technologies Inc
Inspection Date
May 31, 2019
Product Type
Veterinary
Office
Center for Veterinary Medicine
Person
  • Scott N. Lim (Issuing Officer)
View Company Profile

ID · 10314219-0e51-43fd-8750-6414ae31cee6

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1091621
FDA center
Animal Drugs & Feeds
Project area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Outcome
Form 483 issued

FDA Citations

6
  1. 21 CFR 211.84(d)(2)Component written specification
  2. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  3. 21 CFR 211.25(a)GMP Training Frequency
  4. 21 CFR 211.42(c)(7)Quarantined Drug Products Area
  5. 21 CFR 211.192Investigations of discrepancies, failures
  6. 21 CFR 211.56(b)Written sanitation procedures lacking

Full citation text and observation details available on the Dashboard.

Other FDA inspections of GEA Farm Technologies Inc

4
DateClassificationOfficeProject area
January 24, 2017VAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
January 20, 2015NAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
March 27, 2012NAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
September 8, 2009NAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
Other documents for GEA Farm Technologies Inc
  • FDA Inspection 1003146 - 2017-01-24
  • FDA Inspection 910090 - 2015-01-20
  • FDA Inspection 773867 - 2012-03-27
  • FDA Inspection 611300 - 2009-09-08

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