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WARNING LETTER

Whitestone Feeds LLC MARCS-CMS 518413 —


Delivery Method:
UPS
Product:
Animal & Veterinary

Recipient:
Recipient Name
Kenny W. Buckman
Whitestone Feeds LLC

404 East 24th Street

Owensboro, KY 42303
United States

Issuing Office:
Cincinnati District Office

United States


 

   

Black HHS-Blue FDA Logo

 

 

Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772 
 
 

 

July 14, 2017
 
 
WARNING LETTER
518413
 
 
Via United Parcel Service
SIGNATURE REQUIRED
 
 
Kenny W. Buckman, President/Owner
Whitestone Feeds LLC
404 East 24th Street, P.O. Box 99
Owensboro, KY 42303
 
Dear Mr. Buckman,
 
The U.S. Food and Drug Administration (FDA) conducted an investigation of your feed facility located at 62 College Street, Hardin, KY 42048, from December 20, 2016, through January 25, 2017. This inspection was conducted following reports of cattle deaths associated with the consumption of your free-choice protein tub, “(b)(4),” manufactured at your facility. This inspection revealed significant deficiencies which caused the “(b)(4)” to be adulterated within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 342(a)(3)], because it is otherwise unfit for food. You can find the FD&C Act and its implementing regulations through links on FDA’s web page at http://www.fda.gov.
 
In addition, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that an animal food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals, as required by section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)].
 
This inspection resulted in FDA’s issuance of an FDA Form-483, Inspectional Observations, at the conclusion of the inspection. We acknowledge your firm’s response to the FDA Form-483, dated February 8, 2017. We address your firm’s response below.
 
Violations of the FD&C Act
 
Adulterated Animal Food
 
Your free-choice protein tub, “(b)(4),” is adulterated within the meaning of section 402(a)(3) of the FD&C Act [21 U.S.C. § 342(a)(3)], because it is unfit for food. The tubs’ soft consistency allowed for their overconsumption by cattle, which resulted in ammonium toxicity consistent with a lethal ingestion of non-protein nitrogen (NPN) from the feed-grade urea added to the tubs. Specifically:
 
Your firm was notified of 17 head of cattle that died in Alabama and Florida from October 5, 2016, through December 22, 2016, following their consumption of your (b)(4). The State Veterinarian from the Alabama Department of Agriculture and Industry (ADAI) performed necropsies on five of those cattle and reported that the cause of the death appeared to be from ammonia toxicosis. Furthermore, testing by ADAI and the University of Kentucky Regulatory Services found excessive levels of NPN in your (b)(4). Your firm told our investigator that the State Veterinarian informed your firm that chunks of the tub were found in the stomach of one of the cows during the necropsy. Furthermore, your firm told our investigator that the State Veterinarian informed your firm that he sawed one of your protein tubs in half and found that the center of the tub was soft and not cured completely. 
 
Free-choice protein tubs can be too soft if poor mixing and quality control practices during tub manufacturing prevent tubs from curing adequately or if the wet-to-dry ingredient ratio is incorrect, which may also prevent tubs from curing adequately. Your firm told our investigator that your firm sometimes ships tubs to distributors prior to adequate curing, with instructions on the shipping documents that the tubs are not to be sold to producers until additional curing has occurred. Your firm also did not use metering devices to accurately measure the portion of wet ingredient used during the manufacture of your tubs. Furthermore, your firm told our investigator that it has had problems with poor quality corn steep liquor used as an ingredient in the (b)(4) and with the proper mixing of ingredients for your (b)(4).  
 
Under section 301(a) of the FD&C Act [21 U.S.C. § 331] the introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act.
 
We have received your response dated February 8, 2017. In that response, your firm states that it has ordered metering devices to measure wet ingredient, is re-designing the tubing going to the ribbon mixer, and is holding product for release until it receives the results for protein and NPN levels in the product. We acknowledge that your firm initiated a recall of and discontinued the manufacturing of the (b)(4). We also acknowledge that your firm reformulated several of your free-choice protein tubs, including creating a 35% protein tub with less feed-grade urea and other upgraded ingredients, such as corn steep liquor from a new supplier. We will ascertain the adequacy of your corrective actions at our next inspection. 
 
Reportable Food Registry
 
Additionally, you failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that an animal food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such animal food will cause serious adverse health consequences or death to animals, as required by section 417(d)(1) of the FD&C Act [21 U.S.C. § 350f(d)(1)]. Specifically:
 
When notified of animal deaths suspected to be caused by your animal food product, (b)(4), on October 5, 2016, and December 5, 2016, and informed by University of Kentucky Regulatory Services (UKRS) staff of your firm’s responsibility to submit an RFR on December 14, 2016, your firm did not submit the RFR until December 23, 2016, when an investigator from FDA informed your firm of its responsibility.   
 
The Reportable Food Registry was established by section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-085) to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health. It requires a responsible party to file a report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are “Reportable Foods.” The responsible party is the person who submits the registration under section 415(a) of the Act [21 U.S.C. § 350f(d)] for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held. Failure to submit a required report about a reportable food is a prohibited act under section 301(mm) of the Act [21 U.S.C. § 331(mm)].
 
In your response dated February 8, 2017, your firm states that it will submit reportable food reports to the RFR within 24 hours. We will ascertain the adequacy of your corrective action at our next inspection.
 
This letter is not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. You are responsible for ensuring that your firm complies with the FD&C Act and all applicable laws and regulations. You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory or enforcement action without further notice, including seizure and/or injunction. 
 
We also offer the following comment:
 
Also, keep in mind, that as a registered facility your operation will be subject to the Current Good Manufacturing Practice requirements (CGMPs) for food for animals (21 CFR 507, subpart B) in the future. Information about compliance dates can be found here: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm#Compliance_Dates. Animal food that is not manufactured, processed, packed, and held according to CGMPs may be considered adulterated (21 CFR 507.1(a)(1)(i-ii)). Some CGMP requirements to be aware of:
  • Management of the establishment must ensure that all operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting, transporting, and segregating) are conducted in accordance with the current good manufacturing practice requirements of this subpart [21 CFR part 507] (21 CFR 507.25(a)(1)).
  • Management of the establishment must ensure adequate precautions are taken so that plant operations do not contribute to the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials (21 CFR 507.25(a)(5)). 
  • Manufacturing and processing steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling must be done in a way that protects against the contamination of the animal food (21 CFR 507.25(c)(4). 
  • When animal food has become adulterated, management of the establishment must ensure that it is rejected, disposed of, or if appropriate it is treated or processed to eliminate the adulteration. Disposal must be done in a way that protects against the contamination of other animal food (21 CFR 507.25(a)(7)).
  • Raw materials and other ingredients must be examined to ensure they are suitable for manufacturing and processing into animal food. (21 CFR 507.25(b)(1)).
You should notify this office in writing within fifteen (15) business days of receiving this letter of the steps you have taken to correct the violations noted above. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) business days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. You should include copies of any available documentation demonstrating that corrections have been made.
 
Your written response should be sent to Andrew Lang, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237. If you have any questions about this letter, please contact Compliance Officer Andrew Lang at 513-679-2700 x 2117.
 
 
Sincerely,
/S/ 
Steven B. Barber
Director, Division V
Office of Human and Animal Food Operations: East