Article Results (Showing 1 - 10 of 312) RSS Alert
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FDA ups enforcement on marketed unapproved drugs, as KV draws seizure
FDA is placing stronger emphasis on compliance enforcement on manufacturers that produce unapproved drugs, which account for approximately two...
Inspection Monitor, 08/01/08 by Joseph Pickett · More from publication -
Physio Control hit with 32-item 483 for design verification and software flaws
Physio Control, Redmond, WA, was slapped with a 32-item 483 because "design verification did not confirm that the design output meets the design...
Validation Times, 07/01/08 by Joseph Pickett · More from publication -
Quality control problems net Elge 14-item 483
Elge, Rosenberg, TX, received a 14-item 483 because the responsibilities and procedures applicable to the quality control unit were not fully...
Validation Times, 07/01/08 by Joseph Pickett · More from publication -
Discrepancy review flaws nets Altaire 4-item 483
Altaire Pharmaceuticals, Aquebogue, NY, received a four-item 483 for allegedly failing to review any unexplained discrepancy whether or not the...
Validation Times, 07/01/08 by Joseph Pickett · More from publication -
Akorn nets 22-item 483 for validation and quality deviations
Akorn, a drug manufacturer in Decatur, IL, received a 22-item 483 following a 2007 GMP audit because procedures designed to prevent microbiological...
Validation Times, 07/01/08 by Joseph Pickett · More from publication -
Legislation marks significant boost to FDA post-market safety efforts
WASHINGTON -- The Food and Drug Administration Amendments Act (FDAAA) 2007 is a "significant change in the regulatory paradigm," Center for Drugs...
Adverse Event Reporting News, 05/06/08 by Joseph Pickett · More from publication -
Burden of proof of safety must fall on drug manufacturers: Woodcock
Top FDA officials broke ranks with the Bush administration at a recent hearing of a House Energy and Commerce subcommittee, saying they would...
Validation Times, 05/01/08 by Joseph Pickett · More from publication -
Inspector finds Changzhou testing equipment 'unsuitable,' but MOU didn't help FDA get information
An urgent February 2008 audit of the Changzhou SPL plant determined to be responsible for the contaminated heparin that reached 11 countries and...
Validation Times, 05/01/08 by Joseph Pickett · More from publication -
Dingell discussion draft requires inspection prior to importing any drug or device to U.S.; FDA disagrees
The Food and Drug Administration Globalization Act of 2008, by House Energy and Commerce Committee Chairman John Dingell (D-MI), would require "an...
Validation Times, 05/01/08 by Joseph Pickett · More from publication -
FDA policy, IT limits failed in Baxter audit of Changzhou SPL
Baxter International did not send an inspector into the Changzhou SPL plant until February 2007, the inspection lasted only one day, and Baxter...
Validation Times, 05/01/08 by Joseph Pickett · More from publication
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