Comments on: FDA: Heparin Debacle Was An ‘Isolated Incident’ http://www.pharmalot.com/2008/02/fda-heparin-debacle-was-an-isolated-incident/ News, Comment and Conversation Fri, 10 Feb 2012 22:20:37 +0000 http://wordpress.org/?v=2.6.2 By: Malcolm Ross http://www.pharmalot.com/2008/02/fda-heparin-debacle-was-an-isolated-incident/#comment-168364 Malcolm Ross Tue, 19 Feb 2008 20:08:28 +0000 http://www.pharmalot.com/2008/02/fda-heparin-debacle-was-an-isolated-incident/#comment-168364 This is surreal. Can you imagine a pharmacist pleading that he dispensed the wrong drug because he misread the script or a pharma companying pleading with an FDA inspector that a wrong ingredient was put into the product because of a typographical error or a product being released because of a transcription error. Maybe the FDA should abandon its GMP for the 21st century and concentrate on its own GMP for the 20th century first. This is surreal. Can you imagine a pharmacist pleading that he dispensed the wrong drug because he misread the script or a pharma companying pleading with an FDA inspector that a wrong ingredient was put into the product because of a typographical error or a product being released because of a transcription error.
Maybe the FDA should abandon its GMP for the 21st century and concentrate on its own GMP for the 20th century first.

]]> By: Farmanux News http://www.pharmalot.com/2008/02/fda-heparin-debacle-was-an-isolated-incident/#comment-168321 Farmanux News Tue, 19 Feb 2008 19:06:00 +0000 http://www.pharmalot.com/2008/02/fda-heparin-debacle-was-an-isolated-incident/#comment-168321 [...] Weeks or months? [...] [...] Weeks or months? [...]

]]> By: Barry http://www.pharmalot.com/2008/02/fda-heparin-debacle-was-an-isolated-incident/#comment-166777 Barry Tue, 19 Feb 2008 02:09:52 +0000 http://www.pharmalot.com/2008/02/fda-heparin-debacle-was-an-isolated-incident/#comment-166777 Based on other news reports the plant inspected was for bulk chemical APIs. Couldn't the inspectors see that it wasn't set up for heparin. Heparin is a biologic and in this case supposedly of natural origin (pig) wouldn't they expect to see different equipment and a different set up. Something smells fishy about the FDA response. Based on other news reports the plant inspected was for bulk chemical APIs. Couldn’t the inspectors see that it wasn’t set up for heparin. Heparin is a biologic and in this case supposedly of natural origin (pig) wouldn’t they expect to see different equipment and a different set up.

Something smells fishy about the FDA response.

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