NEWS
08/16/1993
FDA announces Warner-Lambert Co to Correct Manufacturing Problems
P93-34 Food and Drug Administration
FOR IMMEDIATE RELEASE Susan Cruzan -- (301) 443-3285
The Food and Drug Administration today announced that the
Warner-Lambert Co. has agreed to correct problems with
manufacturing and testing practices associated with its drug
products, and to bring its facilities into compliance with current
Good Manufacturing Practice regulations (GMPs).
In a consent decree agreed to by FDA and Warner-Lambert, a
U.S. District Court Judge in New Jersey entered a permanent
injunction against the company and its officers. The decree
requires the company to hire independent experts to evaluate
manufacturing records and data for its products and submit written
certifications to FDA that drug products distributed from its six
facilities in the United States, including two in Puerto Rico, meet
the applicable manufacturing standards.
The decree resulted from a series of plant inspections by FDA,
recalls by Warner-Lambert and meetings between the agency and
Warner-Lambert officials. Since December l992, 14 Warner-Lambert
drugs have been recalled for failure to comply with GMPs and
product quality standards. However, none of the recalled products
posed a critical health risk.
"Patients must have confidence that the drugs they take are
properly made," said FDA Commissioner David A. Kessler, M.D. "We
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will continue to work closely with Warner-Lambert to ensure that
its products meet the appropriate standards."
The decree allows several Warner-Lambert drug products that
are considered medically necessary and not otherwise available to
continue to be manufactured and distributed, provided that certain
conditions are met. These products include: Celontin,
Chloramphenicol injection, Choledyl, Dilantin, Humatin, Ketalar,
Loestrin 1/20, Lopid, Milontin, Nardil, Nipent, Nitrostat and
Zarontin.
The consent decree does not affect review of pending new drug
applications. Likewise, certain investigational drugs will
continue to be available.
Manufacture of the company's other prescription drug products
has been suspended pending completion of laboratory and product
certifications. However, the company will be permitted to ship
prescription and over-the-counter products from certain plants in
inventory while the laboratory and product certifications are
completed.
Under the consent decree, Warner-Lambert has agreed to the
following measures:
* An independent expert will certify that each laboratory at
each of the facilities complies with the GMPs.
* All laboratory personnel will be trained so as to be fully
qualified to perform their assigned duties.
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* Outside experts will certify that manufacturing processes
are in compliance with GMPs.
* Expert certifications or compliance plans to correct
deficiencies will be reviewed and approved by FDA for medically
necessary products that are not otherwise available.
To ensure compliance, FDA will continue to conduct inspections
of Warner-Lambert plants and examine records relating to
manufacturing and testing methods. According to the decree, FDA
has authority to require the company to recall any product that
does not meet standards. The agency may also require Warner-
Lambert to stop manufacturing and distributing any product that
fails to comply with GMPs or is not in accordance with the approved
application. The decree further requires Warner-Lambert to pay
damages resulting from violations of the injunction and the
agency's costs associated with this continuing oversight.
The six plants covered under the injunction are located in
Morris Plains, N.J., Lititz, Pa., Rochester and Holland, Mich., and
Vega Baja and Fajardo, Puerto Rico.
FDA is one of eight Public Health Service agencies within HHS.