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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.
- Spring '08