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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
Failing to establish procedures to review and evaluate complaints as well as CAPA procedures landed Alliance Precision Plastics a six-item FDA Form 483 following a March 28 to 30 inspection of its Rochester, New York, 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
Hand Biomechanics failed to complete package integrity validations and had incomplete medical device reporting procedures, the FDA said in a Form 483 issued after a March/April inspection of its Sacramento, California, facility. Read More