Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, Ml 48207
December 4, 2013
Mr. Steve VanRoekel, President/CEO
424 North Riverfront Drive
Mankato, MN 56002
Dear Mr. VanRoekel,
Between July 2 and August 29, 2013, the Food and Drug Administration (FDA) conducted an inspection of your licensed medicated feed manufacturing facility located at 135 Main Street Shipshewana, IN 46565-0156. This inspection was conducted in response to a report of bird deaths after consumption of feed manufactured by your firm, which was found to contain high levels of calcium and phosphorus.
We found that several lots of feed manufactured at your facility had been adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(1)], which states that feed is deemed adulterated if it bears or contains a poisonous or deleterious substance which may render it injurious to health. Furthermore, the feed was misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343], because its labels were false in their declaration of the level of calcium in the feed. In addition, the inspection revealed deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations, Part 225, (21 C.F.R. 225). Such deviations cause medicated feed being manufactured at this facility to be adulterated under section 501(a)(2)(B) the Act, 21 U.S.C. 351 (a)(2)(B). You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
On September 20, 2013, we received a response to the Form FDA-483 issued to your firm on August 29, 2013. We acknowledge that you recalled four lots of affected product and you are taking steps to address the lack of training, manual clarifications, and system recalibrations. However, your response does not completely address the corrective action for the other affected lots or the inadequate review of records, and does not provide evidence of future preventative and corrective actions regarding manufacturing discrepancies. It is your responsibility to ensure that you have fully corrected these deficiencies in your operation and that such violations do not recur. We will confirm your continued compliance with the Act and its associated regulations during our subsequent inspections of your facilities.
Our investigation found violations including, but not limited to, the following:
1. During the inspection, we confirmed that several lots of feed manufactured and distributed by your firm between April and May, 2013, contained excessive levels of calcium. Most of this feed was distributed to local growers and ultimately fed to birds, some of which died after consumption of the feed. Specifically, on 4/25/2013-5/30/2013, you manufactured four lots (B00582621, B00584526, B00578954 and B00570987), approximately (b)(4) tons, of Hubbard Life Homestead FastGrow AM.0125 NAP/NAB with Amprolium, which contained significantly elevated levels of limestone/calcium.
According to the Mineral Tolerance of Animals, 2nd edition by the National Research Council of the National Academies, the maximum tolerable dietary calcium level for growing poultry chicks is 1.5%. Specifically, chick diets containing calcium levels above 2% can depress feed intake and weight gain, and increase mortality rate. In addition, visceral gout and nephrosis can occur in growing pullets fed a 2.5% calcium diet from 8-20 weeks of age. Although your label for Hubbard Life Homestead FastGrow AM.0125 NAP/NAB indicates the product should have calcium levels at a minimum of .8% and a maximum of 1.3%, samples from lot B00570987 were determined by a private laboratory to contain calcium levels above 3.40%. FDA Samples 806272, 806273, and 806274 from lots B00582621, B00584526, and B00578954 revealed calcium levels at 3.2%, 2.6%, and 3.4%, respectively.
Accordingly, the above-mentioned feed manufactured at your facility is adulterated under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(1)], as it contains excessive calcium levels which may render it injurious to health.
2. In addition, according to the samples collected and analytical results for lots B00578954, B00582621, B00584526, and B00570987, the labels are false and misleading as the calcium levels were found above your maximum (1.3%) label guarantee. We find these products to be misbranded under section 403(a)(1) [21 U.S.C. § 343] the Act.
Furthermore, the inspection revealed the following deviations from current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds, Title 21, Code of Federal Regulations, Part 225, (21 C.F.R. 225). Such deviations cause feeds being manufactured at this facility to be adulterated within the meaning of section 501(a)(2)(B) the Act, 21 U.S.C. 351 (a)(2)(B).
3. Significant discrepancies were noted on the batch production records and your firm failed to institute an investigation immediately and describe a corrective action taken on the batch production records, as required by 21 CFR 225.102(b)(4). The following batch production records of Hubbard Life Homestead FastGrow AM.0125 NAP/NAB indicated excessive overages in limestone: B00571078, B00574371, B00575649, B00578954, B00582621, B00584526, and B00588875. Although these significant discrepancies were noted on the batch production records, you failed to immediately investigate and note corrective action on the record. We acknowledge that you subsequently recalled lots B00570987, B00578954, B00582621, and B00584526; however, you did not address the other lots identified with excess limestone, or provide evidence of future preventative and corrective actions regarding manufacturing discrepancies.
4. Your mixing operators did not have an understanding of the manufacturing or control operations which they perform, as required by 21 CFR 225.10(b)(1). Your firm’s mixing operators detected that the limestone/calcium amount added exceeded the set tolerances for Hubbard Life Homestead FastGrow AM.0125 NAP/NAB and “Accepted” the batch without acknowledgement and documented approval of the Plant Manager, as required by your SOP QFS 20 Quality Safety Manual.
The above violations are not meant to be an all-inclusive list of the deficiencies in your facilities. It is your responsibility to assure that all of the products that your facilities manufacture and distribute, as well as your overall operation, are in compliance with the Act and its associated 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 action without further notice such as seizure and/or injunction.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. 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) working days of receiving this letter, state the reason for the delay and the time frame within 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 LCDR Kelli Wilkinson, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact LCDR Wilkinson at 313-393-8120.
Glenn T. Bass
Detroit District Office
Mr. James A. Long, Plant Manager
Hubbard Feeds, Inc.
135 Main Street
Shipshewana, IN 46565