Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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
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
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