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]