Merck & Co. Inc. has been cited by the U.S. Food and Drug Administration for failing to follow proper sterility and testing procedures at its vaccine plant in West Point, Montgomery County, according to federal inspection reports.

U.S. regulators, who inspected the plant in August and again during the fall, found many quality-control problems, including leaking ampules during drug packaging, flawed documentation for rejected drug batches, and workers who did not follow proper sterility procedures, those records say.

Merck, the second-largest U.S. drugmaker, which employs 220 in its vaccine division and 10,000 people at its West Point research campus and two other locations in Montgomery County, makes vaccines for measles, mumps, rubella, chicken pox and hepatitis A and B at the Pennsylvania plant.

In recent months, Merck twice halted production voluntarily at the West Point plant, which has resulted in shortages of some vaccines, said Merck spokesman Christopher Loder.

"We are still shipping every day, but some customers may not get the vaccines within their usual time frame," Loder said.

FDA inspectors visited Merck's West Point plant on Aug. 6 and returned several times between Aug. 27 and Oct. 29.

An FDA spokeswoman said yesterday that the inspection reports were "observations, not conclusions. There's no warning letter. There's been no additional action. They are given time to correct these things."

Loder said Merck "voluntarily interrupted" manufacturing to make changes in response to issues raised by the FDA during a routine inspection.

Manufacturing was halted a second time "in recent months for scheduled modifications to the vaccine facility. That had nothing to do with the FDA," he said.

"Production has resumed, but because the modifications took longer than expected, it has impacted production of some vaccines." Loder declined to say which vaccines are in short supply. "Obviously, we are working very quickly and expeditiously to correct any shortages," he said.

The FDA raised "some issues we voluntarily chose to address. As for specific discussions with the FDA, we don't discuss our specific discussions with regulatory agencies," Loder said.

Vaccines produce about $1 billion in annual revenue for Merck. The drug company reported $40 billion in revenues in 2000.

In the first inspection, regulators found "raw data" in lab notebooks was "being changed with no justification," according to FDA documents. They also found "spreadsheets used to determine questionable results" had "not been validated."

During the second inspection, the FDA detailed violations of federal standards, including unsatisfactory room cleanliness, "systematic human errors" on production lines, and improper airflow in one building, the documents say.

Merck could be fined if the violations continue.

The Merck facility competed with three other companies last fall for a $428 million federal contract to make 155 million doses of smallpox vaccine. A team of Acambis Inc. and Baxter International Inc. won the contract Nov. 28.

Government officials said price was the reason. Merck and GlaxoSmithKline P.L.C. had offered to produce the smallpox vaccine for just under $8 a dose. The winning bid came in at $2.76 per dose.

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Linda Loyd's e-mail address is lloyd@phillynews.com.