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See Latest ArticlesMerck warned by FDA over vaccine plant failings
Corporate News Releases - The Healthcare Sales & Marketing Network, 05/08/08
The agency said Merck had filed an 'inadequate response" to a Form 483 sent to the company several weeks ago, and it now needed to see immediate corrective action. The agency highlighted several areas in which the plant deviated from good manufacturing practices (GMP). For example, Merck is accused of not investigating why some batches of product were outside of specifications, as well as "failure to maintain production and process control," according to the FDA.
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Advisory Committee briefing materials for CRESTOR sNDA available on US FDA web site
AstraZeneca, 12/15/09
Sixteen Fired for Records Snooping
HealthDataManagement, 12/09/09
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