FDA to B&L: Fix violations at lens solution plantNov 6, 2006 | www.democratandchronicle.com
Bausch & Lomb Inc. said today it has received a warning from federal regulators about its response to an inspection of a manufacturing plant involved in the investigation of an outbreak of a rare eye infection in contact lens wearers.
In an 11-page letter to B&L dated Oct. 31, the Federal Drug Administration outlines a series of violations at the company’s Greenville, S.C. plant that it feels have not yet been adequately addressed. The alleged violations include a range of operating practices, including record keeping, cleanliness, inspection and environmental control.
If the violations are not addressed, according to the letter, B&L could face a range of sanctions, including a fine or delays in regulatory approvals of “reasonably related” products. The FDA also said that other federal agencies are advised of the warning letters to evaluate when awarding contracts.
The affected plant made ReNu with MoistureLoc, a contact lens solution tied to reports of Fusarium keratitis involving contact lens wearers in the United States and several foreign countries.
The FDA’s inspection did not link any conditions at the plant to the outbreak of Fusarium, but it did order corrective actions in record-keeping and other operating conditions.
A related investigation by the Centers for Disease Control concluded that ReNu with MoistureLoc was probably not contaminated during the manufacturing process. Instead, the CDC said it was likely the solution has “unique properties” that may have triggered the outbreak. B&L recalled MoistureLoc worldwide earlier in May.
The CDC’s report was based on a controlled study following reports of 164 confirmed cases of Fusarium infections in 33 states and one U.S. territory. Almost 60 percent of the patients reported using ReNu with MoistureLoc.
The outbreak has hovered over B&L for several months. The company earlier this year projected that pre-tax earnings for 2006 would probably be about $80 million, down from initial forecasts. B&L cited costs of the recall and related brand-rebuilding efforts.
In a release today, B&L said the FDA letter contains no new observations; rather, the company says it summarizes the agency’s assessment of B&L’s progress as of June 30.
At an update in mid-August, B&L reported to the FDA it had completed more than half the action items, the company said in its release. That number had increased to two-thirds by early last month, B&L also said, with the remaining items either in process of implementation or assigned new completion dates.
“Of the unfinished actions itemized in the warning letter, the great majority were reported as complete in the Oct. 12 update,” B&L said in its release. Those items cannot be considered closed until the FDA has had an opportunity to review or inspect them, B&L said.