---

---

---

June 13, 2019

 

 

WARNING LETTER

 

 

Overnight Delivery via UPS                                                        Refer to CMS 582496

 

 

Scott A. Stangl, Co-owner

Shane Stangl, Co-owner

Craig Stangl, Co-owner

Allandale Dairy

27231 83^rd Street

Pierz, Minnesota  56364-7634

 

Dear Messrs. Stangl:

 

On March 13 and 20, 2019, the U.S. Food and Drug Administration (FDA or “we”) conducted an inspection of your dairy operation located at 27231 83^rd Street, Pierz, Minnesota.  This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation.  You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.

 

We found that you hold animals under inadequate conditions so that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.  Specifically, you failed to maintain a treatment record for the administration of penicillin to a cow identified with ear tag (b)(4).  Also, your treatment records do not identify the dosage, route of administration, number of injection sites, the person who administered the treatment, and the withdrawal times for meat and milk.  Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

 

The above is not intended to be an all-inclusive list of violations.  As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute complies with the law.

 

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 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 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 CDR Chris van Twuyver, Director, Compliance Branch, West Division 1, at the address on our letterhead.  If you have questions about this letter, please contact CDR van Twuyver at (612) 758-7112.

 

Sincerely,

/S/

Michael Dutcher, DVM

Director, West Division 1

Office of Human and Animal Food Operations

 

 

 

xc:   (b)(4)