From Vaisala
This application note outlines 10 steps towards formulating effective Form 483 responses to offset further agency action. The note also provides several ways to improve quality systems for controlled and critical environments so you can avoid receiving 483s in the first place.
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Topics of Interest
No cGMP compliant manufacturer wants to receive a Form 483 ("Notice of Inspectional Observations"). In such stringently controlled industries as pharmaceutical/biotechnical development, manufacturing...
In 2003, MHRA’s and FDA’s investigation of Chiron’s Fluvirin flu vaccine manufacturing facility in the U.K. brought to light some important cGMP deficiencies. However, since then,...
In 2011, almost three times as many US FDA warning letters and FDA Form 483s were issued to pharmaceutical and biopharmaceutical manufacturers compared to 2010. The companies receiving these citations...
By Michael Gregor, Compliance Gurus, Inc. On June 12, 1992, the United States filed action against Barr Laboratories, alleging that the company had violated sections 331(a) and 351(a) (2) (B) of the...
Agnes Shanley, Editor in Chief “Even if you’re on the right track, you’ll get run over if you just sit there.” the U.S. Food and Drug Administration (FDA) celebrated its hundredth...
