www.fdanews.com/articles/132467-amigo-warning-cites-failures-with-device-master-records
Amigo Warning Cites Failures With Device Master Records
December 6, 2010
A lack of device master records for its motorized scooters resulted in a warning letter for Amigo Mobility International. During a month-long inspection of the Bridgeport, Mich., facility, an FDA investigator found that the scooters were manufactured based only on drawings, according to the warning letter. The company did not have other elements required in a device master record, including production process specifications. Amigo also had not developed design control procedures or documented design control activities for several of its models.
The GMP Letter
The GMP Letter