Leiner Health Products hasn't heard from federal regulators in two months about the company's formal reply to concerns about how it makes drugs, company officials said in a conference call Friday.
In the meantime, Leiner had stopped production at its plants nationwide, costing about 25 percent of the company's total business.
Asked by investors about the delay, Leiner Chief Executive Officer Bob Kaminski said he did not know and could not speculate "out of respect to the FDA."
The agency has not responded to numerous requests from The Herald.
Leiner said Thursday it would lay off about 540 workers at its Fort Mill plant, shutting down manufacturing and packaging operations and keeping about 35 people on for distribution.
The California-based company makes store-brand vitamins, minerals and nutritional supplements. It is the second-largest supplier of over-the-counter pharmaceuticals in the food, drug, mass merchant and warehouse club retail market. Wal-Mart, Sam's Club and CostCo are three of its biggest customers.
Leiner opened a $40 million, 680,000-square-foot facility in 1998. The facility is located in Fort Mill's Lakemont Business Park off Carowinds Boulevard.
Sign of serious problems
The FDA's silence shouldn't be surprising, one analyst said.
"They're not in the business of responding; they're in the business of protecting consumers," said Derek Leckow of Barrington Research. "The FDA is taking this very seriously. There must have been serious problems there before, is the impression I'm getting."
Leiner's biggest competitor in the storebrand market, Perrigo, issued a massive recall of acetaminophen last fall.
That problem was caught by its own internal quality control standards, Leckow said.
"You want to have redundant systems that catch problems," he said. "By the time you get to this stage, things have deteriorated to a point where remedial action has to be taken."
Leiner will meet with the FDA in Atlanta on Tuesday, company officials said. The company is confident it's been doing all it can, including retesting its products, to meet and exceed quality standards. Leiner hopes to stay a major player in the OTC market, executives said, although vitamins and supplements are the company's "bread and butter."
"Every action we have taken has tried to be on the basis of doing the right thing, to show the FDA we're going to get this thing made right," Kaminski said.
A representative from the S.C. Department of Commerce said officials there received a FedEx document from Leiner Friday with information about the layoffs.
The commerce department and Leiner will be working to set up a time for the department's so-called rapid response team to come to the plant and help out the workers, said spokewoman Kara Borie.
That team can help workers file their insurance, find new jobs and retrain for new careers, before their last days of work.
The director of Rock Hill's work force center urged Leiner employees to come to the office, which can help them find jobs, train for new careers and more.
The office is located at 1228 Fincher Road, off West Main Street in Rock Hill.
Call 328-3881 for more information.