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FDA releases results of the Medical Device Manufacture's Survey Evaluation on FDA Quality System/GMP Inspections

You may not have been inspected during this time period, March 1999 to end of April 2000, and could not have participated in a survey that the medical device manufacturers worldwide were asked to take.

At the close of all pre-market and QS/GMP inspections during this time period, the FDA investigator gave a survey packet to a company representative. The survey's purpose was to determine how satisfied medical device firms are with the current FDA inspection process, discover if and where there are any problems with the process, and to foster communications between industry and the FDA.

The survey had 558 respondents and included all medical device companies worldwide, 126 respondents to the survey were foreign companies or 22.6% of the replies. The district with the largest number of replies was from New England with 11.8% of the replies. It was estimated that 40% of the companies returned the survey.

There were several interesting facts that were observed from the survey information.

For one, it appears that approximately 50% of the companies have over 100 employees and 20% have over 1000 employees worldwide. Only 17% of the companies had 10 or less employees.

The survey covers such things as the Reason for the Inspection, QS/GMP only made up 72.5%; Before the inspection information i.e. advance notice times (US companies had a 7.2 Mean and Foreign companies had a 55.5% Mean.); During the Inspection information i.e. length of the inspection with 2-3 days and 4-5 days together made up over 66% (this makes sense since foreign inspection are scheduled to last only a maximum of 4 days); Outcome of the inspection - inappropriate or inaccurate FDA 483 Observations (with 19% inappropriate observation, 11% inaccuracies on the 483 and 25% had one or more FDA 483 inaccuracies or inappropriate observations; and there was an Overall Evaluation of the Inspection in which 52% stated that the experience inspection was better than previous inspections while 40% said it was the same and 8% said it was worse.

This was an interesting survey though I don't think that it was a true representation of what is really going on throughout the industry. At the present time the FDA is very industry friendly and the FDA should be commended on their attempt to improve their operations and communications but how long will this last, until a change in the make up of Congress.

If you want a copy of this survey you can go the FDA website at www.fda.gov/ora/indust_assit/qsgmp/default.htm or contact mdi via our email and request a copy (there will be a small copying and shipping charge.

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