Inspections, Compliance, Enforcement, and Criminal Investigations
All American Coop 3/26/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
March 26, 2014
Via UPS Overnight Delivery
Refer to MIN 14 – 11
Glenn M. Lutteke
All American Cooperative
113 4th Street Southeast
Stewartville, Minnesota 55976
Dear Mr. Lutteke:
The Food and Drug Administration (FDA) and the Minnesota Department of Agriculture (MDA) conducted an inspection of your licensed medicated feed mill, All American Cooperative, located at the above address on September 3-5, and 9, 2013. The inspection investigated a Reportable Food Registry (RFR) incident and covered the Current Good Manufacturing Practice (CGMP) regulations for licensed medicated feed manufacturers.
The inspection documented violations of the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations, including significant deviations from CGMP regulations for licensed medicated feed manufacturers, Title 21, Code of Federal Regulations, Part 225 (21 CFR 225.10 – 225.115). Such deviations cause medicated feed manufactured, processed, packed, or held at your facility to be adulterated under section 501(a)(2)(B) of the Act, 21 U.S.C. § 351(a)(2)(B). In addition, because your firm is not currently registered with the Agency as a drug establishment as required under section 510(j) of the Act, 21 U.S.C. § 360(j), all medicated feeds manufactured at your facility are misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o). Certain medicated feeds manufactured at your facility are also misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), as discussed further below, because their labeling lacks adequate directions for use. Finally, the medicated feeds you manufactured and delivered, which were the subject of the RFR incident discussed further below, were unsafe under section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6), 21 U.S.C. § 351(a)(6), as they contained combinations of drugs not approved for use in animal feed for lactating dairy cows.
The occurrences that led to the RFR incident began on July 26, 2013, when your firm erroneously comingled a medicated feed containing chlortetracycline and tiamulin for swine with another medicated feed containing lincomycin for swine due to equipment and/or software malfunction. This resulted in an adulterated, comingled medicated feed containing an unapproved drug combination. The comingled feed was transferred into a load-out bin for quarantine where it remained for over two weeks before being erroneously transferred to a swing bin, which had previously contained roasted soybeans. On August 15, 2013, the comingled feed was substituted for roasted soybeans in two dairy feeds because the bin had not been deactivated after having held the roasted soybeans. The dairy feeds containing the comingled swine feed were then delivered to a dairy farm, and some of each feed was fed to the dairy herd before the mistake was caught. The feeds you delivered to the dairy farm were unsafe under section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6), 21 U.S.C. § 351(a)(6), as they contained a combination of drugs not approved for use in animal feed.
Medicated Feed CGMP violations observed during the inspection include, but are not limited to, the following:
1. Employees involved in the manufacture of medicated feed lack an understanding of the manufacturing or control operations which they perform, 21 CFR 225.10(b)(1).
For example, as discussed above, a bin was not deactivated when it was emptied one day, and the code was not changed when it was filled with a quarantined feed the next day. The quarantined feed, containing an unapproved combination of drugs, was substituted for roasted soybeans in two dairy feeds.
You responded to the Form FDA 483 issued to your firm at the close of the inspection by a letter dated November 11, 2013. Although your response indicated that you have conducted some refresher training on labeling the ingredient bins, you did not include any information about the training, such as copies of the training materials or list of employees in attendance. Additionally, you did not indicate whether your training included a discussion of your procedures for disposal of manufactured feeds that cannot be salvaged.
2. Equipment used to manufacture medicated feed did not possess the capability to produce medicated feed of intended potency, safety, and purity, 21 CFR 225.30(b)(1). For example:
A. The equipment, software system, or a combination of both, did not consistently deliver medicated feed to the designated receiving bin. You explained to the investigators that periodic malfunctions have in recent years delivered feed to the wrong bins several times every year. Regarding the RFR incident discussed above, you explained that you felt that a malfunction of this type caused the two medicated swine feeds to be comingled. However, you failed to diagnose the cause of these errors and at the time of the inspection you had not implemented manual procedures to ensure medicated feeds are of the intended potency, safety, and purity.
B. The June 2013 annual mixer test showed an average coefficient of variation (CV) of (b)(4)%, which is an unacceptably large value and is evidence that your equipment and manufacturing operations do not result in the manufacture of medicated feed that meets the potency, safety, and purity it is intended to possess.
Although your response to the Form FDA 483 indicated that you are working with the controls manufacturer on the equipment/software malfunctions and that you have adopted a procedure to check weights at load-out or bagging to try to identify any further mistakes, you did not provide any documentation of this change, such as a copy of the procedure. Regarding your response related to your mixer CV of (b)(4)%, you indicated that you have done further testing recently and gotten better results, but you did not submit any copies of these mixer test results to support your assertion.
3. The Master Record Files for medicated feeds failed to contain a copy or description of the label or labeling intended to accompany the medicated feeds in shipment, 21 CFR 225.102(b)(1)(iii).
For example, there is no labeling in your Master Record Files for customer-formula medicated feeds and several other medicated feeds. The lack of labeling in your Master Record Files contributes to other labeling violations discussed below. Although your response to the Form FDA 483 indicated that you have implemented new procedures intended to account for your Master Record File requirements that pertain to labeling, you did not include copies of the new procedure, or any example master record file labels that did not exist at the time of the inspection.
4. Medicated feed is not identified by appropriate labeling which provides the user with directions for use which, if adhered to, will assure that the medicated feed is safe and effective for its intended purposes, 21 CFR 225.80(a). For example:
A. The labeling of multiple bulk customer-formula medicated feeds (including (b)(4)) did not include the drug level in the product.
B. Labeling for a customer-formula medicated feed containing chlortetracycline ((b)(4)) stated: “WARNING Withdrawal times vary by manufacturer. Read label for specific withdrawal time.” But the withdrawal time was not provided.
C. In addition to the failure of the labeling to contain the concentration of the drug, the caution statement (“Do not feed to lactatin[g] dairy cattle”) on the labeling of the customer-formula medicated feed “(b)(4) Dairy Protein” contradicts the direction for use “For increased milk production efficiency....”
These medicated feeds are also misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), because they lack adequate directions for use.
5. Incoming labels and labeling had not been proofread against the Master Record File to verify their suitability and accuracy, nor had a copy been kept, initialed and dated as a record of having been proofread, 21 CFR 225.80(b)(2). Label stock had not been reviewed periodically to discard discontinued labels, 21 CFR 225.80(b)(4).
As noted above, there are no copies of labeling in your Master Record Files for several medicated feeds to enable proofreading of newly printed labeling against the Master Record File. In addition, we found labels for several products, such as (b)(4) Medicated and (b)(4) Medicated, stored near the bagging line for use, which did not correspond with the labels in digitally-maintained Master Record Files. Formulas for these products have changed, necessitating new labeling, but old labels have not been discarded, and are in a location where they could still be used. Proofreading and comparing incoming labels with the labels in the Master Record Files are intended to catch these types of errors.
Although your response to the Form FDA 483 indicated that you are working on making corrections to these specific labels and procedures, you did not enclose copies of any of the corrected labels or written procedures that have been updated.
These failures to comply with the requirements of the CGMP regulations cause medicated feeds being manufactured at this facility to be adulterated within the meaning of section 501(a)(2)(B) of the Act, 21 U.S.C. § 351(a)(2)(B).
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 ensuring 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 and 21 CFR 515.22(c)(2).
Based on the results of the September 3-5, and 9, 2013, inspection, evaluated together with the evidence before FDA when the Medicated Feed Mill 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 to preserve the identity, strength, quality, and purity of the new animal drugs therein. This letter constitutes official notice under the law and provides you an opportunity to correct the above deficiencies.
You should notify this office, in writing, within 15 working days of 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 CGMP violations and to prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, Food and Drug Administration, at the address located on the letterhead. If you have questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
Michael Dutcher, DVM
xc: Doug Lueders
Commercial Feed Program Manager
Dairy & Food Inspection Division
Minnesota Department of Agriculture
625 N. Robert Street
St. Paul, MN 55155-2538