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Becton, Dickinson and Company Message Board

  • Rdhdstrng Rdhdstrng Feb 24, 2000 2:35 PM Flag

    Oh yeah, BD will make a great fit with

    ABT, read the following:

    Tuesday February
    22, 4:02 pm Eastern Time
    Abbott plant cited for
    quality control lapses
    WASHINGTON, Feb 22 (Reuters) -
    Federal health officials have warned Abbott Laboratories
    Inc. (NYSE:ABT - news) about quality control problems
    involving production of a blood chemistry test at a Texas
    manufacturing plant.

    In a nine-page letter released
    Tuesday, the Food and Drug Administration charged that
    Abbott failed to establish and maintain procedures to
    correct problems in the production of its Alcyon Analyzer
    at a facility in Irving, Texas.

    The letter,
    one of hundreds the FDA sends each year, was sent
    February 7 to Abbott Chief Executive Miles White and
    released by the FDA's Freedom of Information office
    Tuesday.

    The violations cited ``may be symptomatic of serious
    underlying problems in your establishment's manufacturing,
    quality assurance and/or quality management systems,''
    the letter said.

    The problems were uncovered
    during FDA inspections from October 26 to December 22,
    the letter said.

    Last November, Abbott agreed
    to pay a $100 million federal fine to resolve
    allegations that it did not follow good manufacturing
    practices at a medical-testing device plant in Illinois.
    Abbott did not admit to any violations.

    The Texas
    inspection was part of FDA's efforts to make sure Abbott was
    implementing new quality assurance procedures at all its
    manufacturing facilities, Abbott spokesman Joe Daab
    said.

    ``That was always our intent,'' Daab said, adding ``we
    plan on fulfilling all FDA requirements as quickly and
    as comprehensively as possible.''

    Daab also
    noted that Abbott recalled the Alcyon device from the
    U.S. market for business reasons but still sells it
    overseas.

    In the letter, FDA officials acknowledged the recall
    but said ``we remain deeply concerned that these
    deviations may impact other devices made at the Irving,
    Texas facility,'' the letter said.

    The warning
    letter released Tuesday is the fourth letter sent to
    Abbott since last March.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • So what is really causing the stock to move? I
      heard about ABT taking over for 10 years, enough
      already! Somethings up, and I hope it isn't ABT. I'm not
      sure who's management is worse. Will I take $48, think
      of all those options at $58...do I hear a flush in
      the background?

    • ABT is the victim of an ongoing FDA vendetta.


      A few months ago Paul Craig Roberts wrote a great
      article in IBD about how the federal and state
      governments have found it easier to plunder industries than
      to tax them. Tart it up with whatever Latin legalese
      you wish, the fine was simply a vehicle to loot
      Abbott and ease the budget.

      Much of the
      regulation nowadays has nothing to do with the quality of a
      product or a specific batch of a product, or its
      suitability for its intended use, but rather with the nature
      of the internal paperwork guiding the process for
      producing it.

      If a pharaceutical product is pure,
      does what it was intended to do, meets its release
      specifications and remains usable for the duration of its
      labeled dating, it is a quality product. A diagnostic
      that gives a good result, meets its release specs and
      performs within spec for its labelled shelflife is also a
      quality product.

      The rest of the requirements are
      just bureaucratic Catch 22, with Big Brother telling
      (in this case highly successful) firms how they ought
      to run their business.

      Adamantane

    • Exussc, cath recall NOT the end of BDX caths. If
      Kaiser stopped ordering all BDX caths, that might be
      significant. Not suggested is it?

      Dorfman...who knows
      HIS take (taken with a liberal dose of salt!)


      As for FDA letter to ABT, and the other 124
      others...one of many. Take a number and get in line. Part of
      doing business which is highly regulated. Is that the
      end of the world? C'mon.

 
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