| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
July 6, 2010
W/L 28-10
Mr. Kevin H. Kruse, President
O.H. Kruse Grain & Milling Company / Western Milling Company
31120 Nutmeg Road
Goshen, California 93227
Dear Mr. Kruse:
A comprehensive inspection / for-cause investigation of your non-FDA licensed feed manufacturing facility called Western Milling Company, located at 310 South 24th Avenue in Phoenix, Arizona, was conducted by an Investigator from the U.S. Food and Drug Administration (FDA) between March 18 and March 31 of 2010. The inspection occurred as part of the investigation of a complaint made by a local dairy farm. During this inspection, significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for medicated feeds, Title 21 Code of Federal Regulations, Part 225 (21 C.F.R. 225), were observed. Such deviations caused the animal feed being manufactured at this facility to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 351(a)(2)(B). In addition, several labeling deviations were observed that cause certain animal feed products manufactured by your firm to be misbranded foods under section 403(a)(1) of the Act, 21 U.S.C. § 342(a)(1).
The U. S. Food and Drug Administration's inspection found that your firm failed to implement adequate safeguards to prevent unsafe contamination in the production of medicated and nonmedicated feeds, per Title 21 C.F.R. 225.165. For example our written cleanout procedure directs mill employees to use (b)(4) as a flush following the manufacture of a medicated feed. The written cleanout procedure mentions "sequencing" but does not explain what sequencing is and does not contain a written sequencing plan. We do not believe this is a sufficient amount of direction to be effective.
We also found that not all deliveries of medicated animal feeds are adequately labeled to assure that the feed can be properly used by the consignee, 21 C.F.R. 225.180. Specifically, we found a number of customer-formula medicated feeds whose label did not contain the directions-for-use or other information relative to the medication that is required by the drug approval regulations.
For example, one product we looked at, a dairy feed containing (b)(4) which was manufactured on (b)(4) had a delivery invoice and a "LOAD IT SHEET" accompanying the shipment. However, neither document contained all of the required drug information, including directions-for-use, as required by 21 C.F.R 558.355.
The above is not intended as an all-inclusive list of violations. As an animal feed 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 Act and its implementing regulations.
The specific violations noted in this letter and in the Inspectional Observations form (the FDA Form 483), issued at the close-out of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the cause of the violations, take prompt actions to connect the violations and prevent their recurrence, and to bring your products into compliance. Failure to achieve prompt corrective action may result in regulatory action, without further notice, such as seizure and/or injunction.
We are in receipt of your letter responding to the FDA Form 483 (dated (b)(4)), signed (b)(6) by Included was a copy of the invoice from the scale service company showing that the scales have been serviced and certified. Also included was a copy of a label for a customer-formula medicated feed that contains (b)(4) and is labeled for dairy cows. The label information regarding (b)(4) is incorrect and still needs some additional work.
Although it appears from the response that you are working toward correcting the deviations noted at your facility, you must adequately implement and maintain each corrective action to ensure its effectiveness.
You should notify this office within fifteen (15) business days of receiving this letter of the steps you have taken to achieve and maintain compliance with the law. Your response should include an explanation of each step being taken to correct the violations noted in this letter. If corrective action cannot be completed within 15 business 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.
Please send your response to:
Blake Bevill
Director of Compliance Branch
U.S. Food & Drug Administration
19701 Fairchild
Irvine, California 92612-2506
Sincerely,
/S/
Director
Los Angeles District Office
