Subject: LyphoMed to Alter Some Procedures Criticized by FDA
Date: Published: 3/21/88 60 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   LyphoMed to Alter
   Some Procedures
   Criticized by FDA
    ---
   By Richard Gibson
   Staff Reporter of The Wall Street Journal

   CHICAGO -- LyphoMed Inc., concurring with criticisms of
its operation by a Food and Drug Administration inspector,
says it will improve manufacturing, testing and
record-keeping procedures.
   But the packager of generic drugs used by cancer, heart
attack and AIDS patients contends that "absolutely no product
was ever shipped to customers that failed to meet relevant
standards of potency, quality and purity."
   As part of its efforts to improve quality control,
LyphoMed said it was transferring 50% of production volume
from its Melrose Park, Ill., plant to facilities in Orlando,
Fla., and Grand Island, N. Y. The company said 73 of Melrose
Park's 291 employees would be laid off.  The FDA inspections
were confined to the Melrose Park plant, where the FDA had
prohibited manufacture of any new drugs.
   Responding to specific criticisms in the FDA report,
LyphoMed told the agency how it already had acted, or
intended, to correct procedures.  But in several instances the
company disputed the inspector's conclusions.
   For example, the inspector reported that some raw
materials labeled "for laboratory use only" had been used as
components in commercial drugs.  But LyphoMed said the vendor
had said the material was high purity grade, and removed the
use-restriction claim.
   As for the inspector's finding that products that hadn't
met official specifications were nevertheless released for
distribution, the company told the FDA that "there were no
inquiries or complaints received" on one lot cited.  But it
acknowledged that sterility test procedures used at the time
"could have provided an opportunity for inadvertent
contamination of the test vials" and said the procedure had
been modified.
   The FDA inspector also had cited the company for allegedly
ignoring approved formulas for some compounds, for making
unauthorized changes in batches and for sloppy
record-keeping.  John N. Kapoor, LyphoMed's chairman and chief
executive officer, told the FDA that a new record-keeping
system was being installed, that new quality-control
personnel were being hired and that "the philosophy or
attitude" at the Melrose Park plant was being revamped.
   Mr. Kapoor called the episode, which has caused LyphoMed's
stock to drop substantially in recent weeks, "a mutually
beneficial experience."

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