WARNING LETTER
CHS Inc./CHS River Plains
MARCS-CMS 642790 —
November 30, 2022
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Jay Debertin
Recipient Title
President and CEO
CHS Inc./CHS River Plains
5500 Cenex Drive
Inver Grove Heights
,
MN
55077
United States
Issuing Office:
Division of Human and Animal Food Operations West I
United States
November 30, 2022
WARNING LETTER
Refer to CMS 642790
Dear Mr. Debertin:
The North Dakota Department of Agriculture (NDDA), under U.S. Food and Drug Administration (FDA) contract, conducted an inspection of your facility, consisting of a grain elevator and a non-FDA licensed, medicated feed mill, CHS River Plains, located at 998 E. Main Street, Strasburg, North Dakota, on June 7, 9, and 23, 2022.
The inspection revealed evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements located in Title 21,
Code of Federal Regulations
, Part 507 (21 CFR Part 507), which cause your products to be adulterated.
1
The failure of the owner, operator, or agent in charge of a covered facility to comply with the hazard analysis and risk-based preventive controls provision of 21 CFR Part 507 (located in subparts A, C, D, E, and F) is a prohibited act.
2
In addition, the inspection revealed evidence of significant violations of the requirements for animal feed containing a Veterinary Feed Directive (VFD) drug (VFD feed), located in Title 21,
Code of Federal Regulations
, section 558.6 (21 CFR 558.6). Failure of a facility to comply with the VFD requirements causes the resulting VFD feed to be unsafe within the meaning of the FD&C Act.
3
A drug is adulterated if it is an animal feed bearing or containing a new animal drug and the animal feed is unsafe.
4
Furthermore, the failure of a facility to follow the VFD requirements causes the VFD feed to no longer be exempt from the requirement that its labeling bear adequate directions for use and as a result, the drug is misbranded if it does not bear adequate directions for use.
5
As described below, your labeling did not bear adequate directions for use.
Lastly, the inspection revealed evidence of significant violations of Current Good Manufacturing Practice (CGMP) for Medicated Feeds, 21 CFR Part 225. Failure of a medicated feed mill to comply with these requirements causes a drug to be adulterated.
6
The introduction or delivery for introduction into interstate commerce of any food or drug that is adulterated or misbranded is a prohibited act.
7
Additionally, the doing of any act to a food or drug after shipment of the food or drug and/or its components in interstate commerce and while the food or drug is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is a prohibited act.
8
You may find the FD&C Act and FDA’s regulations through links on the FDA’s website at
www.fda.gov.
At the close of the inspection you were issued a Form FDA-483, Inspectional Observations (FDA-483). We acknowledge your written response received on July 5, 2022. We reviewed your response and address this response below, in relation to each of the noted violations.
Hazard Analysis and Risk-Based Preventive Controls Requirements
Your animal food facility is subject to the hazard analysis and risk-based preventive controls requirements found in 21 CFR Part 507, subparts A, C, D, E, and F. During the inspection of your facility evidence of a significant violation of these requirements was noted.
You did not conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food you manufacture, process, pack, or hold at your facility to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 507.33(a).
Specifically, you did not identify the known or reasonably foreseeable hazards of fumonisin and deoxynivalenol (DON or vomitoxin) for all grains and their co-products that you receive and use as ingredients at your facility, that are susceptible to fumonisin and vomitoxin, such as corn and oats. You also did not evaluate the severity of the illness or injury if these hazards were to occur, or the probability that they would occur in the absence of preventive controls, to determine whether they require a preventive control.
Your response to the FDA-483 contained a signed food safety plan including a hazard analysis. The hazard analysis identifies mycotoxins at the “Bulk Ingredient” and “Bulk Ingredient Storage” steps as a hazard not requiring a preventive control. The justification for the decision states, “Management is responsible for determining the frequency of aflatoxin testing due to regional susceptibilities to aflatoxin contamination.” Your response is not adequate because your justification does not include an evaluation of fumonisin and DON. In addition, you did not provide the methodology used to determine the sample size, frequency, or parameters to identify “regional susceptibilities” for your aflatoxin testing, so we are unable to evaluate it.
Furthermore, your response indicates that you will evaluate your raw material receiving procedures and develop testing and recording processes by July 10, 2022. We encourage you to submit your new mycotoxin procedures so that we can assess them.
Veterinary Feed Directive (VFD) Requirements and Labeling Requirements
As a VFD feed distributor, your facility is subject to the VFD requirements found in 21 CFR 558.6. During the inspection of your facility it was noted that you distributed animal feed containing a VFD drug in a manner that did not comply with the terms of the VFD, as required by 21 CFR 558.6(c)(2).
Specifically, on
(b)(4)
, you distributed
(b)(4)
bags (50 lbs. each) of Aureomycin (chlortetracycline) 10g crumbles under VFD order
(b)(4)
, dated
(b)(4)
. However, your invoices demonstrate you subsequently refilled and distributed
(b)(4)
bags (50 lbs. each) of Aureomycin 10g crumbles on
(b)(4)
, and
(b)(4)
, under VFD order
(b)(4)
. VFDs for chlortetracycline may not be refilled.
9
Furthermore, the VFD states that “[r]eorders (refills) are not permitted with this VFD drug.”
As noted above, your facility’s failure to follow the VFD requirements by not complying with the terms of the VFD causes your VFD feed to no longer be exempt from the requirement under section 502(f)(1) of the FD&C Act that its labeling bear adequate directions for use. You told the investigator that what is printed on invoices is the only labeling information that the customer receives from your firm. Your invoices do not include all of the elements required for drug labeling under 21 CFR 201.5. For example, your invoices did not include indication, or frequency and duration of use. As a result, the Aureomycin drug you distributed is misbranded under section 502(f)(1) of the FD&C Act.
Your response to the FDA 483 states “feed personnel will be retrained on VFD and the local manager will verify the correct usage of all VFDs.” We are unable to evaluate the adequacy of your response as you did not provide documentation regarding whether training had occurred or details as to how the location manager verifies the correct usage of all VFDs.
Medicated Feed Current Good Manufacturing Practice (CGMP) Requirements
Your facility is required to follow the medicated feed CGMP regulations for non-licensed, medicated animal feed manufacturers found in 21 CFR 225.120-202. During the inspection, the following significant violations were observed:
1. You failed to ensure that all deliveries of medicated feeds, whether bagged or in bulk, are adequately labeled to assure that the feed can be properly used, as required by 21 CFR 225.180.
10
Specifically, your firm uses invoices as labeling that accompanies bulk feed that you manufacture and distribute to your customers. Six out of six invoices (
(b)(4)
) reviewed for medicated feeds containing monensin (Beef Balancer R1200) failed to include: feeding instructions, indications for use, and drug concentration. Additionally, 21 CFR 558.355(d)(6) requires all monensin-containing formulations to bear the caution statement, “Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal.” Your labeling did not include this caution statement.
Your response to the FDA-483 states you adapted your process to include labels with deliveries and, if necessary, specific feeding instructions. We are unable to evaluate the adequacy of your response as you did not provide supporting documentation such as your new labeling process and examples of your new labeling.
2. You failed to ensure that a Type B medicated feed, containing monensin, was used in accordance with the drug’s labeled mixing directions, as required by 21 CFR 225.142.
Specifically, on
(b)(4)
, your facility manufactured and distributed an approximate
(b)(4)
-ton lot of medicated feed using 1000 lbs. of Beef Balancer R1200, (a Type B medicated feed) with a concentration of 1,200g/ton of monensin. Labeled mixing instructions for the Beef Balancer R1200 state to mix 50 lbs. to 1,950 lbs. of non-medicated ration for improved feed efficiency in feedlot cattle. Per these mixing
10 See also 21 CFR 507.27(b).
instructions, you should have added only approximately 230 lbs. of Beef Balancer R1200 to this lot of medicated feed. Additionally, the lot you manufactured contained more than three times the amount of monensin approved for this use under 21 CFR 558.355(f)(3)(i).
Your response states that a mixing error did not occur; rather, you failed to supply adequate feeding instructions to the producer. We are unable to evaluate your response, as you did not provide supporting documentation indicating this lot was intentionally manufactured superpotent for further mixing before feeding. Your response also did not provide any labeling for this product that would ensure the superpotent feed could be used properly.
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal action including, without limitation, seizure and injunction.
For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
“Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals”
https://www.fda.gov/media/97464/download
“Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”
https://www.fda.gov/media/110477/download
“Draft Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – Supply Chain Program”
https://www.fda.gov/media/113923/download
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent to the U.S. Food and Drug Administration, 250 Marquette Avenue, Minneapolis, MN 55401, to the attention of Dianna Sonnenburg, Compliance Officer. If you have questions, you may contact Ms. Sonnenburg at Dianna.Sonnenburg@fda.hha.gov.
Sincerely,
/S/
CAPT Greg Smith, PharmD
Acting Program Division Director – West Division 1
Office of Human and Animal Food Operations
cc: Chad A. VanderLaan
Location Manager
CHS River Plains
998 E. Main Street
Strasburg, ND 58573-0437
Todd Oster
General Manager
CHS River Plains
503 North Potter Street
Gettysburg, SD 57442
_____________________________
1
See Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 342(a)(4), and 21 CFR 507.1(a)(1)(ii).
2
See Section 301(uu) of the FD&C Act, 21 U.S.C. § 331(uu).
3
See Section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and 21 CFR 558.6(a)(3)).
4
See Section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6).
5
See Section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1); see also section 504(a)(1) of the FD&C Act, 21 U.S.C. § 354(a)(1).
6
See Section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. § 351(a)(2)(B), and 21 CFR 225.1(b)(1).
7
See Section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).
8
See Section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).
9
See 21 CFR 558.128(d)(2)
Content current as of:
12/20/2022
Regulated Product(s)
Animal & Veterinary
Drugs