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U.S. Department of Health and Human Services

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Enforcement Actions

CHS Nutrition 8/25/09

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486·8788
FAX: 425-483-4996


August 25, 2009


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


John D. Johnson, President and CEO
CHS Inc.
5500 Cenex Drive
Inver Grove Heights, Minnesota 55077


In reply refer to Warning Letter SEA 09-26


WARNING LETTER


Dear Mr. Johnson:


An inspection of your licensed medicated feed mill, CHS Nutrition, located at 300 West Feedville Road, Hermiston, Oregon, on January 27, 28, 29, 30, and February 2, 3,4,6, 17, 18, 19, and 20, 2009, conducted by the U.S. Food and Drug Administration (FDA) found significant deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations, Part 225 (21 C.F.R. 225)). These cGMP deviations cause feeds being manufactured at this facility to be adulterated within the meaning of section 501 (a)(2)(8) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 351 (a) (2)(8). In addition, your firm's use of the Type A, medicated article, fenbendazole, in the manufacture of medicated feeds after the drug reached its labeled expiration date causes the new animal drug fenbendazole to be deemed unsafe within the meaning of section 512 (a)(1) of the Act, 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501 (a)(5) of the Act, 21 U.S.C. § 351 (a)(5). Further, the use of expired fenbendazole to produce medicated feed causes the medicated feed to be unsafe under section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501 (a)(6) of the Act, 21 U.S.C. § 351 (a)(6). The inspection also confirmed that you produced an animal feed that was adulterated within the meaning of section 402(a)(2)(C)(i) of the Act, 21 U.S.C. § 342(a)(2)(C)(i), in that it contained a food additive, selenium, that was unsafe within the meaning of section 409(a)(2) of the Act, 21 U.S.C. § 348(a)(2).


Our investigation found deviations from applicable cGMP regulations including, but not limited to, the following:


1. Failure to conduct potency assays on at least three representative samples of each feed required to be manufactured by a licensed medicated feed mill at periodic intervals during the calendar year as required by 21 C.F.R. § 225.58(b)(1). For example:


a. During the 2008 calendar year, your medicated feed mill in Hermiston, Oregon, manufactured (b)(4) batches of medicated feed using fenbendazole (Safe-Guard), a Category II, Type A medicated article, without performing any of the required assays. 

 

b. Also, during the 2008 calendar year, your medicated feed mill manufactured (b)(4) batches of medicated feed using Aureozol 250, a Category II, Type A medicated article containing chlortetracycline, sulfathiazole, and penicillin, without performing any of the required assays.


c. In addition, during the 2008 calendar year, your medicated feed mill manufactured at least (b)(4) batches of medicated feed using Aureo S 700, a Category II, Type A medicated article containing chlortetracycline and sulfamethazine; however, the required assays were performed on only one representative sample of feed containing
Aureo S 700 during the 2008 calendar year.


2. Failure to implement investigations and corrective actions and maintain documentation of such corrective action,as required by 21 C.F.R. § 225.58(d), when results of laboratory assays of drug components indicated that medicated feeds were not within permissible assay limits. Specifically, an assay of medicated feed, identified under Sample I.D. M134660, submitted for amprolium analysis on October 3, 2008, determined an amprolium level of 73.6% of the theoretical level, which was not within the permissible assay limits of 80-120% of the theoretical level for this medicated feed. There is no record of any corrective action with respect to this medicated feed.


3. Failure to use methods or controls for the manufacture, processing, packing, or holding of medicated feed to ensure that the use of drugs conform to or are in conformity with the New Animal Drug's approval to assure that such medicated feed meets the requirement of the Act, as required by section 512(a)(1 )(A) of the Act, 21 U.S.C. § 360b(a)(1 )(A)]. Specifically, you manufactured medicated feed using drugs that were past their expiration date as follows:


a. During 2008, (b)(4) batches of Safeguard 4% Premixes were made using Safeguard (fenbendazole) drugs that expired in October 2006.


b. During 2008, (b)(4) batches of Safeguard 4% Premixes were made using Safeguard (fenbendazole) drugs that expired in January 2008.


4. Failure to maintain equipment in a reasonably clean manner so as to have the capability of producing a medicated feed of intended potency and purity, as required by 21 C.F.R. § 225.30(b)(2). Specifically, your firm's (b)(4) ribbon mixer was not maintained in a clean manner, as evidenced by the build-up of 3 to 4 inches of feed residues on the shaft and ribbons of the mixer.


5. Failure to maintain accurate drug receipt records to indicate the supplier's lot number or other identifying number for each lot of drug received, as required by 21 C.F.R. § 225.42(b)(5). For example:


a. On or about November 17, 2008, your firm received (b)(4) 50-lb bags of Aureo S 700 (chlortetracycline and sulfamethazine). The shipment received included one bag from Lot Number (b)(4) 80056 (b)(4) bags from Lot Number (b)(4) 80021, and (b)(4) bags from Lot Number (b)(4) 80075; however, the firm drug receipt records list all (b)(4) bags of the shipment under Lot Number (b)(4) 80056.


b. On or about March 25, 2008, your firm received one 25-lb bag of SafeGuard (fenbendazole) identified with Lot Number 87138028; however, the firm misidentified the Lot Number of this drug in its receiving record as 1221156.


c. On or about April 21, 2008, your firm received (b)(4) 50-lb bags of Aureozol 250 (chlortetracycline, sulfathiazole, and penicillin); however, the firm failed to record the Lot Number of this drug in its receiving record.


d. Also on or about April 21, 2008, your firm received (b)(4) 50-lb bags of Amprolium 25%, which was identified with the Lot Number (b)(4) 057; however your firm misidentified the Lot Number of this drug in its receiving record as 1287563.


e. On or about July 8, 2008, your firm received (b)(4) 50-lb bags of Amprolium 25%, which was identified with the Lot Number (b)(4) 042; however your firm misidentified the Lot Number of this drug in its receiving record as 1318424.


In addition to the above-mentioned deviations from cGMP regulations, you also adulterated the drug fenbendazole when you used an expired drug to manufacture medicated feed. Specifically, you used an expired Type A medicated article containing fenbendazole, to manufacture medicated feed. Use of the expired Type A, medicated article, fenbendazole, in the manufacture of medicated feeds causes the new animal drug fenbendazole to be deemed unsafe within the meaning of section 512 (a)(1) of the Act, 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501 (a)(5) of the Act, 21 U.S.C. § 351 (a)(5), and the resulting feed to be unsafe under section 512 (a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501 (a)(6) of the Act, 21 U.S.C. § 351 (a)(6). 


Our investigation also revealed that you produced an animal feed that was adulterated within the meaning of section 402(a)(2)(C)(i) of the Act, 21 U.S.C. § 342(a)(2)(C)(i), in
that it contained a food additive, selenium, that was unsafe within the meaning of section 409(a)(2) of the Act, 21 U.S.C. § 348(a)(2). Specifically, on November 25, 2008,
your firm manufactured a 0.25% Selenium premix at your feed mill in Hermiston, Oregon. This premix used (b)(4) pounds of a 2% selenium salt to make a (b)(4) batch of selenium premix. After the manufacture of the selenium premix, a swine feed, labeled as 45/120 Grower T40 Medicated; Lot Number 3436.88112508m419380, was manufactured and your firm did not perform a flush between the Selenium premix and the swine feed. Analysis of samples of this same lot of medicated swine feed, which were collected during the course of the investigation, confirmed that it contained excessive levels of selenium. The analysis of a sample from Lot 3436.88112508m419380 of your product "45/120 Grower T40 Medicated," a medicated feed intended for swine, found that it contained at least 47 parts per million (ppm) selenium.


We acknowledge your firm's written response, dated February 20, 2009, outlining your corrective intent regarding the observations on the Form FDA 483, Inspectional Observations (483), left with the firm that same day. We also acknowledge and appreciate the corrective efforts your firm has made with regard to your recall and subsequent destruction of the feeds containing the excessive levels of selenium, and with regard to your recall and subsequent destruction of the lots of feeds containing expired drugs.


With respect to feeds with excessive levels of selenium, your firm's response states that you will not make selenium premixes and instead purchase them from an outside vendor; however, your response did not address the underlying issue of your firm's failure to use reasonable and effective procedures regarding equipment used in the processing and mixing of finished feed to prevent adulteration of the manufactured feed. Specifically, you did not address your firm's failure to perform a flush between mixing a product containing highly toxic levels of a food additive, namely selenium, and mixing a finished feed.


With respect to the other violations listed above, we acknowledge your intent to conduct potency assays on at least three representative samples of each feed, to implement investigations and corrective actions when results of laboratory assays of drug components indicate that medicated feeds are not within permissible assay limits, and to maintain equipment in a reasonably clean manner; however, we note that your firm made similar promises of correction when these same violations were reported on a Form FDA-483 left with your firm during an inspection of your Hermiston, Oregon feed mill, on August 21, 2003.


The above is not intended to be an all-inclusive list of violations. As a manufacturer of medicated and non-medicated feeds, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.


You should take prompt action to correct these violations and you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory and/or administrative sanctions. These sanctions include, but are not limited to, seizure, injunction, and/or notice of opportunity for a hearing on a proposal to withdraw approval of your Medicated Feed Mill License under section 512(m)(4)(B)(ii) of the Act, 21 U.S.C. § 360b(m)(4)(B)(ii), and 21 C.F.R. 515.22(c)(2).


Based on the results of the January-February 2009 inspection, evaluated together with the evidence before FDA when the Medicated Feed License was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of medicated feeds are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drug therein. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies in your operations.


You should notify this office, in writing, within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations. Your response should include an explanation of each step being taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.


Please send your written response to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021. If you have questions regarding any issue in this letter, please contact Mr. Donovan at (425) 483-4906.


Sincerely,
/S/

Charles M. Breen
District Director


Enclosure:
Form FDA 483


cc: Kent R. Hansen, Plant Manager
CHS Nutrition, 300 West Feedville Road, Hermiston, Oregon 97838


Oregon Department of Agriculture
Animal Health and Identification Division, Feed Program
635 Capitol Street NE, Salem, Oregon 97301-2532
Attention: Richard Ten Eyck