A nine-day FDA inspection at Alpha Medical Instruments in Mission Viejo, CA, in August found Quality System Regulation violations in the firm’s manufacturing of angiographic balloon catheters.
November 4, 2014
By Jim Dickinson
A nine-day FDA inspection at Alpha Medical Instruments in Mission Viejo, CA, in August found Quality System Regulation violations in the firm’s manufacturing of angiographic balloon catheters, according to an October 7 warning letter from FDA's Los Angeles District Office.
Specific violations shown on an FDA-483 included the following:
Failing to establish procedures for corrective and preventive action;
Failing to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
Failing to validate according to established procedures a process whose results cannot be fully verified by subsequent inspection and test;
Failing to develop, conduct, and monitor production processes to ensure that a device conforms to its specifications;
Failing to have the device history record demonstrate that the device was manufactured in accordance with the device master record; and
Failing to adequately establish requirements that must be met by suppliers.
FDA wrote that Alpha Medical’ September 2 responses to all the inspection observations were found to be inadequate.
The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET]
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