Brief: Boule Diagnostics Receives Warning Letter From US FDA Authority

Boule Diagnostics AB

08/10/2018 08:36

Oct 8 (Reuters) - Boule Diagnostics AB  BOUL.ST :
    * SAID ON FRIDAY UNIT BOULE MEDICAL RECEIVED A WARNING
LETTER FROM
THE US FOOD AND DRUG ADMINISTRATION
    * ACCORDING TO WARNING LETTER, IMPLEMENTED MEASURES ARE
INSUFFICIENT AND ADDITIONAL DOCUMENTATION OF IMPLEMENTATION AND
IMPLEMENTATION OF STAFF TRAINING UNDER NEW PROCEDURES, AS WELL
AS REVIEW OF HISTORY IS REQUIRED



    
 Source text for Eikon:  urn:newsml:reuters.com:*:nWkr72mT0D
    
 Further company coverage:  BOUL.ST  
   


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