-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, GPA73GiKNb8JLwa7hEA8aR0lnKrOati8hLRTBhIL1T8YFKaG4Y0t7RrQXuDOaWH0 7rj5oJ/LjDVeiWf1gZoE6A== 0001096906-10-000307.txt : 20100322 0001096906-10-000307.hdr.sgml : 20100322 20100322165344 ACCESSION NUMBER: 0001096906-10-000307 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20100322 ITEM INFORMATION: Other Events FILED AS OF DATE: 20100322 DATE AS OF CHANGE: 20100322 FILER: COMPANY DATA: COMPANY CONFORMED NAME: UTAH MEDICAL PRODUCTS INC CENTRAL INDEX KEY: 0000706698 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 870342734 STATE OF INCORPORATION: UT FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12575 FILM NUMBER: 10697022 BUSINESS ADDRESS: STREET 1: 7043 S 300 WEST CITY: MIDVALE STATE: UT ZIP: 84047 BUSINESS PHONE: 8015661200 8-K 1 utahmedicalprod8k03222010.htm UTAH MEDICAL PRODUCTS, INC. 8-K MARCH 22, 2010 utahmedicalprod8k03222010.htm



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549

FORM 8-K

Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934

 
Date of Report (date of earliest event reported): March 22, 2010


Commission File No. 001-12575


UTAH MEDICAL PRODUCTS, INC.
(Exact name of Registrant as specified in its charter)


                   UTAH                      
 
      87-0342734       
(State or other jurisdiction of
 
(I.R.S. Employer
incorporation or organization)
 
Identification No.)


7043 South 300 West
Midvale, Utah  84047
Address of principal executive offices


Registrant's telephone number:  (801) 566-1200

 
 

 
 

 
ITEM 8.01 OTHER EVENTS
 



On March 22, 2010, Utah Medical Products, Inc. issued a press release announcing the conclusion of a FDA Inspection to assess its compliance with the Quality System Regulation.  A copy of the press release is attached hereto as Exhibit 99.1



 
SIGNATURES
 



Pursuant to the requirements of the Securities Exchanges Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


 
 
UTAH MEDICAL PRODUCTS, INC.
 
REGISTRANT
     
Date:                      3/22/10                     
By:
/s/ Kevin L. Cornwell
   
Kevin L. Cornwell
   
CEO
 


 
EXHIBIT INDEX

Index
Number                              Description

99.1
Press release issued March 22, 2010: Utah Medical Products, Inc. Announces Conclusion of FDA Inspection
 
 

EX-99.1 2 utahmedical8k03222010ex991.htm PRESS RELEASE ISSUED MARCH 22, 2010: UTAH MEDICAL PRODUCTS, INC. ANNOUNCES CONCLUSION OF FDA INSPECTION utahmedical8k03222010ex991.htm



EXHIBIT 99.1

Salt Lake City, Utah - Utah Medical Products, Inc. (Nasdaq: UTMD) announces that two FDA investigators have concluded a full QSIT inspection used to assess a medical device manufacturer's compliance with the Quality System Regulation (QSR) and related regulations. The inspectional process, known as the "Quality System Inspection Technique" or QSIT, guides field investigators in conducting an efficient and effective comprehensive inspection, focusing on key elements of a firm's quality system.

FDA investigators use a Form FDA 483 to notify management in writing of significant objectionable observations which, in the investigator’s judgment, indicate a medical device is adulterated or prepared under conditions where the device may become adulterated.  At the conclusion of the UTMD inspection last Friday, the FDA investigators determined that there was no need to issue a Form FDA 483.  In the industry, this is known as a “clean” inspection and evidence that FDA investigators have concluded that the Company is in compliance with FDA requirements for manufacturing medical devices. UTMD appreciates the professionalism and objectivity of the recent investigators.

UTMD believes that this is significant since this inspection was the first FDA inspection of the Company since 2004.  After the 2004 inspection, the FDA filed a lawsuit against UTMD alleging that the Company had significant objectionable conditions. The lawsuit was adjudicated in Federal Court in 2005 with the Court concluding completely in UTMD’s favor and finding that UTMD’s quality system was in compliance with the QSR.

According to CEO Kevin Cornwell,
“For anyone – customers, potential customers, clinicians, hospital administrators and others in the medical device supply chain - who had doubts or concerns that the FDA had issues with UTMD’s quality system, the results of this recent inspection should lay those to rest. The millions of UTMD devices used in critical care situations with expected outcomes are clear evidence that UTMD’s quality system overall is working as intended in the QSR, and consistent with UTMD’s decades of commitment to excellence.”

Utah Medical Products, Inc., with particular interest in health care for women and their babies, develops, manufactures, assembles and markets a broad range of disposable and reusable specialty medical devices.
 
 

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