Federal inspectors criticize Bausch & LombMay 17, 2006 | Atlanta Journal-Constitution
The Bausch & Lomb contact lens solution being recalled worldwide and linked to an outbreak of serious eye infections was put on the market without being fully tested for effectiveness in killing bacteria and fungus, according to an inspection report by the U.S. Food and Drug Administration.
ReNu with MoistureLoc, used by 2.3 million Americans, never went through a full FDA approval process, the report indicates, and the company's new-product design team failed to complete a wide range of tests both before and after it was sold to consumers.
After its introduction, as complaints came in that the product could be linked to a spike in cases of rare fungal infections, the company failed to quickly notify the FDA, as required by law, according to the report released Tuesday of inspectors' observations at Bausch & Lomb's lens solution plant in Greenville, S.C.
FDA and Bausch & Lomb officials said they don't think any of the eight pages of problems cited in the report contributed to the worldwide outbreak of fusarium keratitis, a potentially blinding eye infection caused by a common fungus.
But a consumer advocacy group found the report troubling.
"It looks like at almost every step of the way the company was sloppy, careless, and the safeguards that were supposed to be in place were ignored," said Diana Zuckerman, president of the National Research Center for Women & Families, which specializes in medical product safety issues.
The company on Monday announced it is permanently pulling ReNu with MoistureLoc from the market worldwide because it appears the formula allows the fungus to grow when consumers aren't careful in their care and storage of lenses.
Steven Niedelman, the FDA's deputy associate commissioner for regulatory affairs, cautioned that the report is preliminary and based on the inspectors' observations inside the plant. Now higher-ranking FDA officials will examine the report to determine whether documents back up those observations.
"We're going to be very carefully assessing this report," Niedelman said. "If action needs to be taken, we'll take those actions that are appropriate."
Bausch & Lomb officials would not answer specific questions about the FDA report. In a written statement, the company said it communicated promptly with the agency about fusarium infections and that it is taking appropriate corrective actions for other issues cited at the plant.
The South Carolina plant is the sole maker of all Bausch & Lomb contact solutions sold in North America and most of Asia.
Prior to this inspection, which occurred between March 22 and May 15, the FDA hadn't inspected the plant in three years. Indeed, the agency allowed the company to go into production with the new MoistureLoc product in 2004 without any inspection to validate the manufacturing practices, according to the new report and interviews with FDA officials.
Contacts and their solutions are considered medical devices and are regulated by the FDA.
Tim Ulatoski, the FDA's compliance director in its center for devices, said Monday the agency will be looking into why there wasn't an inspection at the time of the new product launch
"We're taking a look at the history there and actually how the process rolled out," he said. "I can't give you a firm statement or conclusion" about whether the FDA should have done an inspection prior to the MoistureLoc product launch.
By statute, the FDA is supposed to inspect all plants at least once every two years, but it rarely does. While a new product launch might trigger an inspection, it doesn't always, agency officials said.
The plant was cited for "significant" lapses in manufacturing processes in May and June 2002, including concerns about the appropriate amounts of preservative/disinfectant in eye care products and flaking ceiling paint chips in product-filling rooms, according to the document.
After a March 2003 reinspection found the problems were fixed, the FDA didn't visit the plant again until it began investigating the fusarium outbreak this March.