FDA Bans GE From Making X-Ray Machines
Seems the FDA is banning General Electric (GE) from making X-ray machines due to problems as its plants in both Utah and Massachusetts according to Forbes. The FDA filed a consent decree in US District court in Utah on Friday, January 12, 2007.
FDA Bans GE From Making X-Ray Machines - Forbes.com:
This relates back to problems discovered initially in an inspection in Nov-Dev 2004 and resulted in a warning letter dated Mar 31 2005. Here is the actual warning letter. The FDA found that the devices were:
adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacture, packing, storage, or installation are not in conformance with the Quality System/Good Manufacturing Practice (QS/GMP) for Medical Devices Regulation, as specified in Title 21, Code of Federal Regulations (21 CFR), Part 820.
And here is the actual FDA announcement;
GE OEC Medical Systems Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies
Seems the FDA inspection that occurred July-Aug 2005 did not show the required responses to the past warning letter and led to the FDA enforcement. From reading the announcement above it appears that GE did not validate the device design and failed to have a corrective and preventive actions program.
GE stopped shipping the units in September and will not be allowed to distribute them until they pass another inspection. GE have also had to recall several models.
I think it likely you will see more medical device manufacturers come under scrutiny mainly because, from my limited exposure to medical device manufacturers, they do not have as form an understanding of the cGMP requirements as the biotech and pharmaceutical industries do. Also, the concept of “validating the device design” is relatively new and some device manufacturers do not seem to be aware of the guidance documents entitled Design Control Guidance For Medical Device Manufacturers released by the FDA in March 1997 to address this very issue .
Technorati Tags: FDA, FDA enforcement, GE, medical device, cGMP, x-ray machine
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