First ruff draft - However, when the firm failed to meet...

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Over the past six years, Abbott has failed to comply with FDA's Good Manufacturing Practice and Quality System (GMP/QS) regulation. Despite warnings from FDA, Abbott has failed to correct its problems. Abbott's manufacturing practices first raised FDA concern in 1993, when deficiencies in good manufacturing practice were found during FDA inspections of the firm's Abbott Park, Ill., and North Chicago, Ill., manufacturing facilities. Violations were found in process validation, production and process control, and corrective and preventive action. After these inspections, FDA sent a warning letter to Abbott in March 1994. Subsequent FDA inspections during 1995, 1996, 1997 and 1998 continued to find the same types of deficiencies. FDA tried to work with Abbott to correct these problems without seeking relief from the courts.
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Unformatted text preview: However, when the firm failed to meet promised completion dates and failed to correct problems adequately, FDA sent another warning letter in March 1999 and re-inspected the facilities during May, June and July. During that inspection, FDA found continuing deficiencies and decided that a court order would be necessary to ensure that the firmís processes were brought into compliance in a timely and orderly fashion. Under the consent decree, signed by Abbott and two of its top corporate executives, FDA will allow the firm to continue distributing certain medically necessary tests for screening blood donors for infectious blood-borne diseases such as HIV, hepatitis B and hepatitis C. Such tests are already subjected to lot release by FDA as an additional control, and there is no evidence that they have been ineffective....
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This note was uploaded on 03/25/2010 for the course BUS 210 taught by Professor Scottrought during the Spring '08 term at University of Phoenix.

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