FDA Closes Vaccine Plant for Violation

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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.

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