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FDA Wants Corrections at Two Medicated-Feed Mills

At 985 locations around the United States, companies hold medicated feed licenses from the U.S. Food and Drug Administration (FDA). These licenses are held by some of agribusiness’s biggest names —Tyson’s, Cargill, Perdue, Foster Farms, Land O’ Lakes —  and by companies you’ve never heard of.

Once a feed mill has gone through the FDA process of successfully completely a Form 3448 application, it joins the industry that can put antibiotic growth promoters in feed for cows, pigs, and other animals. FDA recently told Congress that the medicated feed mill industry accounts for 80 percent of the annual antibiotic use in the United States.

 FDA inspects feed mills for animals just as it does food manufacturing facilities for humans.

Two recent examples of inspection include the Culpeper Farmers’ Cooperative Inc. in Virginia and and the Knight Feedlot Inc. in Lyons, KS. Both received warning letters from FDA after recent inspections.

The licensed medicated feed mill located in Culpeper, VA was inspected last Jan. 25 through Feb. 11 and received a May 17 warning letter about “significant deviations” from Current Good Manufacturing Practice (CGMP) for Medicated Feeds, which causes its medicated product to be considered adulterated, under the law.

FDA said the Virginia mill’s non-medicated feed was also bad because it was “contaminated with filth.”  Further, FDA said:

  • The feed mill and warehouse were not maintained in a clean and orderly manner.

  • Rodents, birds, and other pests could access the buildings.

  • Spoiled feed and damaged bags on the floor, along with trash, were providing a steady food supply and attraction for rodents, mice, and other pests.  Rodent excreta pellets were found throughout the building.

  • Drug components used in the medicated feeds had not been properly controlled to assure their identity, strength, quality and purity once they were incorporated into a product.

  • Rodent excreta pellets were found inside a bag of Deccox 6 percent, a Category I Type A medicated article.

  • Pesticides were not being handled or stored in a manner to prevent cross-contamination with feed products.

  • Insecticide was being improperly stored with drugs, and rodenticide was being used in other areas of the facility without proper controls.

  • Record keeping, including the daily drug inventory, was cited for deficiencies.

Culpeper responded to the Form 483 report, issued after the March 3 inspection, in a letter to FDA, but the agency said it found the steps the feed mill had taken to date still did not “assure and preserve to the identity, strength, quality, and purity of the new animal drug therein.”

A May 23 warning letter to the Knight Feedlot concerned findings from an inspection that occurred on various days between last Dec. 14 and Jan. 4.   FDA  also found Knight’s medicated feed products to be legally defined as adulterated because of “significant deviations” it found from the regulations:

  • Daily drug inventory records were not being properly kept, and medicated feeds containing two different drugs were “not within the permissible limits and no investigation or corrective action was documented.”

  • There were multiple examples of drug inventories failing to exhibit the correct lot number.

  • A Master Record File was not being kept.

  • Failure in the mixing area to property identify, store, handle, and control drugs.

  • Drugs were not being weighed and counted correctly.

Knight responded to the Form 483 inspection report in a letter to FDA on Jan. 31.  FDA acknowledged that Knight is “working toward correcting the deviations,” but needed to understand its responsibilities as a operator of a licensed (medicated) feed mill.

FDA has issued medicated feed mill licenses to 15 firms in Canada, and to 970 other  establishments in the following U.S. states:

AL – 20

AR – 30

AZ – 03

CA – 39

CO – 28

DE – 05

FL – 11

GA – 51

IA – 90

ID – 17

IL – 25

IN – 23

KS – 58

KY – 12

LA – 09

MA – 02

MD – 08

ME – 01

MI – 10

MN – 59

MO – 39

MS – 21

MT -0 7

NC – 43

ND – 10

NE – 45

NH – 01

NM – 01

NY – 08

OH – 20

OK – 29

OR – 07

PA – 30

PR – 05

SC – 07

SD – 16

TN – 09

TX – 95

UT – 08

VA – 11

VT – 03

WA – 13

WI – 32

WV – 01

WY – 01

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