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WARNING LETTER

Alpha Feed Mill, Inc MARCS-CMS 570812 —

Product:
Animal & Veterinary
Drugs
Animal Feed

Recipient:
Recipient Name
Brice R. Weber
Recipient Title
Co-Owner and President
Alpha Feed Mill, Inc

2741 North 150 Avenue
Alpha, IL 61413
United States

Issuing Office:
Division of Human and Animal Food Operations East V

550 West Jackson Blvd., Suite 1500, South
Chicago, IL 60661
United States


WARNING LETTER

FY2019-HAFE6-03

 

March 4, 2019

 

VIA UPS Next Day

 

Brice R. Weber, Co-Owner and President

Kelly J. Weber, Co-Owner and Secretary

Alpha Feed Mill, Inc.

2741 North 150 Avenue

Alpha, IL 61413

 

Dear Mr. and Ms. Weber,

The U.S. Food and Drug Administration (FDA) conducted an inspection of your licensed medicated feed manufacturing facility located at 2741 N. 150 Ave., Alpha, IL on August 23, 2018 through September 28, 2018. The inspection revealed deviations from the current good manufacturing practice (CGMP) requirements for medicated feeds. Such deviations cause the medicated and non-medicated animal feeds manufactured at your facility to be adulterated.[1] Furthermore, the inspection revealed deviations for the requirements for veterinary feed directive (VFD) requirements and as a result you are not using your VFD new animal drugs in accordance with their approval. Therefore, the VFD drug is considered unsafe and the resulting VFD feed is adulterated.[2] 

Certain medicated feeds manufactured at your facility are also misbranded because their labeling lacks adequate directions for use.[3]  In addition, certain medicated feeds manufactured at your facility are misbranded because its labeling does not identify the drug and its quantity in the animal feed and fails to include the required cautionary statements.[4],[5]

Medicated feed CGMP requirements are in Title 21, Code of Federal Regulations, Part 225 (21 CFR 225). Veterinary Feed Directive (VFD) requirements are in Title 21, Code of Federal Regulations, Part 568.6 (21 CFR 568.6). You can find the Federal Food, Drug, and Cosmetic Act and FDA regulations on the Internet through links on FDA’s web page www.fda.gov.

Adulterated Animal Food - VFD

During the inspection of your facility, FDA Investigators noted observations on a Form FDA 483, Inspectional Observations, issued to you on September 28, 2018. These observations include violations of the veterinary feed directive requirements (21 CFR Part 558.6) which demonstrate you are not using your VFD drugs in accordance with their approval. Violations observed during the inspection include, but are not limited to, the following:

You failed to obtain a written (nonverbal) acknowledgement letter from a receiving distributor (consignee) prior to distributing a VFD feed to another distributor, as required by 21 CFR 558.6(c)(8). 

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators observed that between January 8, 2018 and August 10, 2018 you distributed Type B and Type C VFD feeds containing Neo-Oxy 10/10 (Neomycin and Oxytetracycline) to other distributors on over six different occasions. These were distributed prior to receiving a written (nonverbal) acknowledgement letter. Examples of such instances include the following:

A.    (b)(4) of Neo-Oxy 10/10, a Type B medicated feed containing neomycin and oxytetracycline, was sold to a distributor on June 22, 2018.

B.    (b)(4) shipments of a Type C medicated feed each containing (b)(4) of Neo-Oxy 10/10 was sold to a distributor on June 28, 2018.

C.    (b)(4) shipments of a Type C medicated feed each containing (b)(4) of Neo-Oxy 10/10 was sold to a distributor on June 20, 2018.

D.    A Type C medicated feed containing (b)(4) of Neo-Oxy 10/10 was sold to a distributor on June 21, 2018.

The distribution of a feed containing a veterinary feed directive drug prior to obtaining a written (nonverbal) acknowledgement letter from a receiving distributor (consignee), causes your animal feeds containing a veterinary feed directive drug to be unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C.360b(a)(1)] and the resulting VFD feed is considered adulterated under section 501(a)(6) of the FD&C Act [21 U.S.C. 351(a)(6)].

Adulterated Animal Food – Medicated Feed CGMPs

During the inspection of your facility, FDA Investigators noted observations on a Form FDA 483, Inspectional Observations, issued to you on September 28, 2018. The violations of the medicated feed CGMP regulations for licensed medicated animal food manufacturers (21 CFR Part 225.1-225.115) renders your medicated and non-medicated animal food adulterated according to Section 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(2)(B)] and 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)].  

Violations observed during the inspection include, but are not limited to, the following:

1.    You failed to initial and date proofread labels as a record of having been proofread against the Master Record File to verify suitability and accuracy, as required by 21 CFR 225.80(b)(2).

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators observed the product labels for your Distiller Balancer 1000 RM and 15% Optimizer Creep R90 which contains monensin, and Feedlot 40-20 B500 which contains lasalocid were observed as not being initialed and dated by a responsible individual signifying that they were proofread prior to use. This is significant because the labeling for the Distiller Balancer 100 RM was observed as lacking the drug declaration for monensin, the drug quantity in the feed, and failed to include the required caution statements including but not limited to the caution statement that monensin ingestion is fatal to horses, as required by 21 CFR 558.355(d).

Additionally, your master record files for your Distiller Balancer 1000 RM, 15% Optimizer Creep R90 and Feedlot 40-20 B500 formulas and labels provided by third party animal nutritionists for entry into your (b)(4) database are not signed and dated signifying that master files had been reviewed and checked by a responsible individual prior to use. This is a repeat violation from the March 22-23, 2017 and January 8-10, 2014 inspections where it was noted that your firm failed to document the review of master formulas and labeling.

The failure to proofread formulas and labeling prior to use provides opportunities for incorrect formulas and labeling to be used during the manufacture and distribution of medicated feeds resulting in the distribution of adulterated and misbranded product. 

2.    You failed to provide appropriate labeling that accompanies your bulk custom blend medicated feeds to the user with directions for use which, if adhered to, will assure that the medicated feeds are safe and effective for their intended purposes, complete labeling shall accompany the shipment and be supplied to the user at the time of delivery. Such labeling may consist of a placard or other labels attached to the invoice or delivery ticket, or manufacturer's invoice that identifies the medicated feed and includes required information for the safe and effective use of the medicated feed, as required by 21 CFR 225.80(b)(3). 

Required labeling that provides the user with directions for use must include feeding directions so that the animals receive the drug at the approved rate. Conditions of safe and effective use of Carbadox in swine are specified in 21 CFR 558.115. The label for Grady Weaner 150 w/MDX does not include feeding directions to ensure the consuming swine receive the drug at the approved rate.

The failure to provide the required labeling, allows opportunities for your medicated feeds to be fed in a manner inconsistent for its safe and effective use.

3.    You failed to properly identify, store, handle and control drugs in the mixing areas to maintain their integrity and identity, as required by 21 CFR 225.42(b)(4).

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators observed you had (b)(4). of Paylean 9 (NADA 140-863), Lot # C500689, with an expiration date of 06/2018, available for use in your drug storage area. On July 10, 2018 you manufactured a custom feed ration with ticket/invoice number (b)(4) using the expired Paylean 9, lot # C500689. Additionally, you sold (b)(4). of the expired Paylean 9 directly to a customer on July 19, 2018. 

In order to maintain a new animal drug’s integrity, you should not use or distribute expired new animal drugs which may no longer have the correct potency.  

4.    You failed to maintain your equipment to facilitate inspection and use of cleanout procedures, as required by 21 CFR 225.30(b)(6).

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators observed that the entry access to the (b)(4) mixer did not allow for ease of access, in that the bolts used to close the access entry were rusted on the mixer. The mixer operator stated that the mixer had not been entered or cleaned in at least 6 years. In addition, the following was observed, indicating that your equipment was not maintained in a manner that facilitates inspection and use of cleanout procedures:

A.    The hatch covering the dump grate for the (b)(4) mixer in the mixing area, had broken hinges.

B.    The west exterior wall of the cooler for the pellet mill had a hole approximately 2 inches by 6 inches.

C.    The chain in the cooler for the pellet mill which pulls the conveyor belt holding the recently pelleted product was broken and non-functional. 

The failure to maintain your equipment in a way where it can be cleaned out as necessary may result in animal food adulteration issues, including but not limited to, unsafe drug carryover between batches of animal food.

5.    You failed to maintain all equipment in a reasonably clean and orderly manner, as required by 21 CFR 225.30(b)(2).

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators observed a thickness of approximately 2 inches of buildup of molasses and other feed related material covering the hand add grate to your (b)(4) mixer. Also, the canvas boot which connects the dump hopper to the mixer had approximately 2 inches by 2 inches of canvas missing.

This is a repeat violation from the March 22-23, 2017 and February 10-11, 2015 inspections where it was noted that your mixer had excessive material build-up. The failure to maintain equipment in a reasonably clean and orderly manner can allow excessive ingredient build-up to break loose, resulting in unsafe carryover of new animal drugs in subsequent batches of animal food.

6.    You failed to maintain your building in a reasonably clean and orderly manner, as required by 21 CFR 225.20(b)(2).

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators observed in the basement:

A.    A pile approximately 4 feet high and 10 feet wide of spilled feed and/or feed ingredients located by the pellet mill, while the remainder of the approximate (b)(4) square foot basement had spilled product covering the floor that was 12-24 inches deep.

B.    Live insects, too numerous to count, on top of the spilled product covering the floor of the basement.

C.    Your facility’s ceiling covered with copious amounts of dust and insect webbing. 

This is a repeat violation from the March 22-23, 2017 inspection where it was noted that your facility was in a state of uncleanliness with excessive material build-up.  Failing to maintain your buildings in a reasonably clean and orderly manner can provide harborage to rodents, insects, and other pets which may contaminate the animal food.

7.    Rodenticides (pesticides) have not been handled and stored in a manner intended to prevent cross contamination with feed products, as required by 21 CFR 225.35.

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators observed improper use and storage of pesticides in the basement and in the warehouse where finished feed is stored. Rodenticides shall not be used in areas where animal feeds are manufactured or stored including where raw material are stored. Any rodent boxes containing a rodenticide must be placed in appropriate locations outside the manufacturing and storage areas. 

The failure to properly handle and store rodenticides (pesticides) where animal feeds are manufactured or stored could result in the contamination of animal food with the pesticide.

8.    You failed to ensure buildings and grounds used to produce medicated feeds are constructed and maintained in such a manner to minimize vermin and pest infestation, as required by 21 CFR 225.20.

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators observed the following:

A.    Two live rodents in the grain filled basement of your facility on August 23, 2018.

B.    Birds nesting and roosting in the bulk load-out and bulk receiving buildings and in the upper and lower warehouse. Ingredients and finished bagged product stored in the warehouse was observed with bird excrement on the packaging. Additionally, bird excrement was observed on the floor throughout the warehouse.

C.    Multiple rodent tunnels were observed along the north and south exterior walls of the bulk load out building.

D.    An approximate 3 feet high by 12 feet wide pile of corn was observed on August 23, 2018 below one of the exterior grain bins; however, this pile of corn was still present on September 28, 2018. Spilled feed and grain will attract pests.

E.    In the upper warehouse there was a hole approximately 6 inches by 2 feet along the floor and wall junction. Finished bagged cattle feed was stored adjacent to the hole in the warehouse wall.

The failure to maintain your buildings and grounds in a way that minimizes pest infestation has resulted in the presence of rodents in your facility in a way that may result in the contamination of animal food.

Misbranded Animal Food

During the inspection of your facility on August 23, 2018 through September 28, 2018, FDA Investigators reviewed your animal food labels and determined several of your products are misbranded under section 502 of the Act [21 U.S.C. § 352].

1.    Between January 8, 2018 and August 10, 2018, you distributed Type B or Type C medicated feeds containing Neo-Oxy 10/10 (Neomycin and Oxytetracycline) to other distributors on over six different occasions. The labeling of these Type B and Type C medicated feeds were distributed without a VFD or acknowledgment letter as required under the statute and regulations for the distribution of VFD feeds.[6] VFD feeds that are distributed in compliance with these requirements are exempt from the requirement that their labeling bear adequate directions for use under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. Because your VFD feeds were not distributed in compliance with the statutory and regulatory requirements, your VFD feeds are misbranded because they do not bear adequate directions for use as required by section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].

2.     Review of your formula for Distillers Balancer 1000 RM lists Rumens in 90 (90g/lb monensin) as an ingredient. However, the label found within your master record file for the Distillers Balancer 1000 RM failed to include the drug declaration for monensin and the drug quantity in the feed and failed to include the required caution statement. Specifically, the label fails to include the following caution statement, “Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal.” as required by 21 CFR 558.355(d)(6). The failure to declare the drug, monensin, and its quantity causes the product to be misbranded under section 502(e)(1)(A)(ii) of the Act [21 U.S.C. 342(e)(1)(A)(ii)] and the failure to include this cautionary statement causes the product to also be misbranded under section 502(c) of the Act [21 U.S.C. 342(c)].

3.    During the inspection of your facility on August 23, 2018 through September 28, 2018, the labeling for the medicated feed, Grady Weaner 150 w/MDX, was observed as not including labeling that provides the user with directions for use including information on the limitations of the approval. To assure that the medicated feed, Grady Weaner 150 w/MDX is safe and effective for its intended purposes it must include the following limitations found in the Carbadox approval:

A.    The medicated feed should not be used in pregnant swine or swine intended for breeding purposes [21 CFR 558.115(d)(2)(ii)].

B.    The limitation statement in the approval, “Do not be fed to swine within 42 days of slaughter” [21 CFR 558.115(d)(2)(ii)].

C.    Does not indicate the special consideration “Do not use in Type B or Type C medicated feeds containing bentonite” [21 CFR 558.115(c)].

D.    Does not list the indication for use [21 CFR 558.115].

The failure to provide the user with directions for use including information on the limitations of the approvalincluding its cautionary statements causes the product to be misbranded under section 502(c) of the Act [21 U.S.C. 342(c)].

Corrective Actions

We acknowledge your promised corrective actions during the inspection which included providing the required labeling for custom bulk feeds, implementing a cleaning schedule, making needed repairs to buildings and equipment, and reviewing master formulas and associated labels for accuracy.  However, promised corrections will have to be verified during subsequent follow-up inspections. In addition, during the inspection you stated you would respond in writing to the observations listed on the FDA 483, Inspectional Observations. As of the date of this Warning Letter, we have not received a written response to the FDA Form 483, Inspectional Observations, issued to you at the close of the inspection on September 28, 2018.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the cause of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory and/or administrative sanctions without further notice. 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 FFD&C Act and 21 CFR 515.22(c)(2). This letter constitutes official notification under the law.  Based on the results of the August 23, 2018 through September 28, 2018 inspection, 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 drugs therein. This letter notifies you of our findings and provides an opportunity to correct the above deficiencies.

It was noted during the August 23, 2018 through September 28, 2018 inspection that your firm’s drug establishment registration expired on December 31, 2011, thus your firm is not registered with the Agency as a drug establishment as required under section 510(b) of the Act [21 U.S.C. § 360(b)]. Licensed feed mills are required to register as a drug establishment (21 CFR 207.9 and 207.13(g)). Failure to register as a drug establishment renders all medicated feeds manufactured at your facility during the time your facility is not registered as a drug establishment misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)]. Your prompt attention to this matter is requested.

Your firm is currently licensed as a medicated feed manufacturer. A license to manufacture medicated feeds is required when a facility manufactures medicated feed utilizing a Category II Type A Medicated Article. If you no longer wish to manufacture medicated feed using a Category II Type A medicated article, you may cancel your medicated feed license and you do not need to renew your drug establishment registration. If you so choose to cancel your license, please include your decision in your response to this Warning Letter.

Furthermore, your facility is now subject to the Current Good Manufacturing Practice Requirements for Food for Animals regulations found in 21 CFR part 507.  Facilities that are required to register with FDA as a food facility under section 415 of the FD&C Act and are manufacturing, processing, packing, or holding medicated feed under 21 CFR part 225 are also subject to the Current Good Manufacturing Practice (CGMP) requirements in 21 CFR part 507, subpart B.  These regulations provide baseline food safety and sanitation standards for facilities manufacturing, processing, packing, and holding both medicated and non-medicated animal food.  Animal food that is not manufactured, processed, packed, and held in accordance with CGMPs may be considered adulterated (21 CFR 507.1(a)(1)(i-ii) and sections 402(a)(3) and (4) of the FD&C Act).  Animal food facilities that are subject to specific CGMPs, such as medicated feed CGMPs, must comply with those requirements as well as the requirements in part 507, subpart B (21 CFR 507.1(c)).  For more information, please see FDA’s Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf.   

In addition, you are now subject to the Hazard Analysis and Risk-based Preventive Controls requirements in 21 CFR part 507, subparts C and E, unless an exemption applies (21 CFR 507.5).   According to these requirements, you must develop and implement a food safety plan.  Specifically, a preventive controls qualified individual (PCQI) must prepare, or oversee the preparation of, a written hazard analysis to identify known or reasonably foreseeable hazards.  The PCQI, or designee, must evaluate identified known or reasonably foreseeable hazards to determine if your firm has any hazards requiring a preventive control to significantly minimize or prevent the hazard.  Please see FDA’s draft Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM592870.pdf.

Section 743 of the FD&C Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. 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.

Your firm’s response should be sent to, Dr. Byron Ho, DVM, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Dr. Byron Ho at (313) 393-8262 or via email byron.ho@fda.hhs.gov.

  

Sincerely,

/S/                                                           

William R. Weissinger, MS

Chicago District Director

Office of Human and Animal Food Operations

Division East 6


[1] Section 501(a)(2)(B) of the Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] and 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)] apply to medicated and non-medicated food, respectively.

[2] Section 512(a)(1) of the Act, 21 U.S.C. §360b(a)(1) and section 501(a)(6) of the Act, 21 U.S.C. § 351(a)(6).

[3] Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]

[4] Section 502(e)(1)(A)(ii) of the Act [21 U.S.C. 352(e)(1)(A)(ii)]

[5] Section 502(c) of the Act [21 U.S.C. 342(c)]

[6] Section 504(a)(1) of the Act [21 U.S.C. 354(a)(1)] and 21 CFR 558.6(c)(8)).