Inspections, Compliance, Enforcement, and Criminal Investigations
Doon Elevator Company 25-May-07
Department of Health and Human Services
Public Health Service
Kansas City District
May 25, 2007
RETURN RECEIPT REQUESTED
Ref. KAN 2007-08
Leonard D. Hoekstra, President
Doon Elevator Company
301 Gere Avenue
P.O. Box 97
Doon, Iowa 51235
Dear Mr. Hoekstra:
An investigation of your feed mill, Doon Elevator Company, Doon, Iowa, conducted by a Food and Drug Administration (FDA) investigator on March 6 and 8, 2007, found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for Medicated Feeds, Title 21, Code of Federal Relations, Part 225 (21 CFR 225). Such deviations cause feeds being manufactured at this facility to be adulterated within the meaning of section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drugs chlortetracycline, penicillin, and carbadox to be unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)].
Our investigation found deviations including, but not limited to, the following:
• Some medicated articles and/or medicated feeds are not used in accordance with their labeled mixing directions. [21 CFR 225.142] For example, you have manufactured and distributed medicated feeds containing drug combinations not approved by FDA. During the inspection, it was observed that medicated feeds had been manufactured containing the combinations of chlortetracycline with carbadox and penicillin with carbadox, neither of these combinations is approved. It is your responsibility to make sure that when drugs are used in combination in medicated feeds, that they have been approved for use in those combinations. [See 21 CFR 558.3(a)] Because your use of these drugs did not conform with their approved applications, you caused them to be unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)].
• The production records are not adequate to facilitate a recall of specific batches of medicated feeds, if necessary. [21 CFR 225.202] For example, the investigator observed a log documenting that the current lot of Pulmotil in use was # [redacted] when a physical inspection found that lot # [redacted] was the actual the when indicates records are not adequate to facilitate a recall of specific actual batches of medicated feed.
• Deliveries of bulk medicated feeds are not adequately labeled to assure the proper use of the feed. [21 CFR 225.180] For example, we observed that the labeling accompanying bulk medicated feeds do not contain feeding directions or indications for use statement. Please note that we do not object to the use of the invoice as labeling, however it must contain all the required label information.
The above is not intended as 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 comply 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 correct these violations promptly may result in regulatory sanctions. These sanctions include, but are not limited to, seizure and injunction.
Furthermore, we strongly recommend that you establish written procedures to ensure the mixers used in the production of medicated and non-medicated feeds are properly cleaned to assure the feeds you produce are not unsafely contaminated. During the inspection, the investigator noted that you do not have a written cleanout procedure for your employees to follow, that you do not document how feeds are sequenced or if flushing was performed, and you have not demonstrated the alleged flushing is effective in practice. Establishing written procedures will help ensure that you comply with the requirements in 21 CFR 225.165 that adequate procedures are used for all equipment used in the production and distribution of medicated feeds to avoid unsafe contamination of medicated and nonmedicated feeds.
In addition to the observed CGMP and other violations, we also note that under Section 704 of the Act [21 U.S.C. § 374], FDA has authority to inspect your facility at reasonable times and within reasonable limits and in a reasonable manner. During the inspection, we believe that you denied FDA reasonable access to your facility when you limited the time available for the FDA investigator to complete her inspection and therefore hindered FDA's ability to complete its inspection as provided by Section 704.
You should notify this office, in writing, within fifteen (15) working days of receiving 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 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 response should be directed to Ralph J. Gray, Compliance Officer, at the above address.
John W. Thorsky
Kansas City District