October 8, 2018 / 7:39 AM / 2 months ago

BRIEF-Boule Diagnostics Receives Warning Letter From US FDA Authority

Oct 8 (Reuters) - Boule Diagnostics AB:

* 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

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Further company coverage: (Gdynia Newsroom)

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