Bausch & Lomb on November 6 announced that it has received a warning letter from the United States Food and Drug Administration relating to an inspection the agency conducted at the company’s Greenville, S.C. solutions manufacturing plant during the period March 22 through May 15, 2006 in connection with reports of Fusarium keratitis from some users of “ReNu with MoistureLoc” solution produced in the facility. Although the inspection did not identify any conditions at the manufacturing facility that contributed to or caused the reported adverse events, it identified some important issues that the company is addressing through a series of corrective actions. The Warning Letter contains no new observations, but rather documents those corrective actions still in process. Bausch & Lomb voluntarily initiated a global recall of its “ReNu with MoistureLoc” lens care solution on May 15.
In response to the FDA’s report on the inspection observations (FDA Form 483), the company immediately initiated a series of corrective actions and submitted a comprehensive plan summarizing those actions on June 30. The warning letter summarizes the agency’s assessment of the corrective actions completed as of the company’s June 30 response. Since that time, the company has continued to keep the FDA updated on its progress toward completing the corrective actions outlined in its response to the Form 483.
At an update with agency representatives in mid-August, the company reported having completed more than half of the action items. In a report submitted on October 12, which the agency has yet to finish reviewing, the company reported that more than two-thirds of the action items had been completed; that the majority of the outstanding items were in the process of implementation according to schedule; and that a handful had been assigned new completion dates. Of the unfinished actions itemized in the warning letter, the great majority were reported as complete in the October 12 update, although, of course, they cannot be considered closed until the FDA has had the opportunity to review or inspect them.
Bausch & Lomb said that it has taken very seriously its responsibility to respond with appropriate speed and thoroughness to the FDA’s observations. The company has confidence in the products it manufactures at the facility based on the processes and systems in place. Bausch & Lomb is committed to completing the remainder of the action items in its corrective plan according to schedule, and expects to be ready for a re-inspection in the first quarter of 2007.
