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By Ed Silverman
Merck & Co. has been cited
by federal regulators for numerous quality-control problems
at a manufacturing plant where several important vaccines
are made.
The Food and Drug
Administration issued two enforcement reports -- extensive
reviews of manufacturing practices -- following inspections
of a Merck plant in Pennsylvania this past summer and fall.
After the second
report was compiled in November, the Merck executive in charge
of vaccine operations at the West Point, Pa., plant took early
retirement, according to a company memo.
The FDA found Merck
improperly performed procedures for sterility, testing and
documentation, among other things.
They were noticed
by regulators at the same time Merck bid on -- and lost --
a $428 million contract to make smallpox vaccine for the federal
government.
Such inspections
are routine in the pharmaceutical industry, but lengthy enforcement
reports aren't -- the second report was 22 pages. Ultimately,
Merck could face stiff fines if enough serious violations
are found over a prolonged period.
Meanwhile, people
familiar with the situation say production at the plant has
been halted while new supervisors are trained. Between 300
and 400 people work there.
Among the problems
the FDA found at Merck:
- Timely inspections
weren't performed after noticing sterility failures.
- Discrepancies
in the number of rejected batches weren't documented.
- Spreadsheets
used to determine questionable results weren't verified.
- Sufficient air
pressure in the building wasn't maintained properly.
The FDA typically
doesn't comment on inspections that haven't yet been resolved,
but an FDA source said the Merck case remains open.
Products made at
Merck's Building 29, part of a huge research and manufacturing
facility in West Point, include
- Varivax, a chicken
pox vaccine;
- a vaccine for
MMR, or measles, mumps and rubella; and
- vaccines for
Hepatitis A and B.
Vaccines
generated only about $1 billion in sales
for Merck last year out of total revenue of $21
billion. But Merck has repeatedly identified vaccines as a
growth engine. For instance, the company is working on an
AIDS vaccine.
The
Star Ledger January 8, 2002
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