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Failure to establish design controls, acceptance procedures or a quality policy for its MiBo Thermoflo Class II device landed specification developer and manufacturer Mibo Medical Group a Form 483 following a May inspection of its Dallas, Texas facility. Read More
Failure to maintain complaints from 2014 to 2017 landed Phoenix, Arizona-based Gergens Orthodontics Lab a Form 483 following a May FDA inspection. Read More
The firm had not defined, documented or implemented design control procedures that addressed design input, outputs, review, verification, validation or design changes, according to the nine-item 483. Read More
Failure to maintain complaints from 2014 to 2017 landed Phoenix, Arizona-based Gergens Orthodontics Lab a Form 483 following a May FDA inspection. Read More
Failure to establish design controls, acceptance procedures or a quality policy for its MiBo Thermoflo Class II device landed specification developer and manufacturer Mibo Medical Group a Form 483 following a May inspection of its Dallas, Texas facility. Read More
A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product — plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 FDA inspection of its Dayton, Ohio facility. Read More