FDA Issues Statement on Preliminary Bausch & Lomb Inspection Findings; 'Objectionable Conditions' Noted

PharmaManufacturing.com
05/16/2006

Click here to access a copy of FDA's 483 citation (an 11-page PDF document) of Bausch & Lomb.

On May 15, the Food and Drug Administration (FDA) issued Bausch & Lomb a report detailing its observations at the conclusion of the inspection of the Greenville, S.C. plant and a related facility as part of an investigation into a recent increase in Fusarium keratitis infections associated with contact lens wearers using the ReNu with MoistureLoc contact lens cleaning solution. An FDA 483 ("Inspectional Observations"; see download instructions, right) issued by the agency details the investigator's observations that were found to deviate from FDA quality system regulation.

On March 22, 2006, investigators from the FDA's Atlanta District Office began inspections of Bausch & Lomb's Greenville, S.C. manufacturing plant and a related facility to identify any possible source of Fusarium. During the inspection, FDA and the Centers for Disease Control and Prevention (CDC) conducted extensive sampling and testing as part of the joint investigation. Preliminary results to date from testing of environmental factors, raw materials, in-line manufacturing processes and finished products have not found that these factors have contributed to Fusarium contamination. Laboratory testing is ongoing.

Bausch & Lomb has proposed the ReNu with MoistureLoc formulation as the potential root cause of the increased relative risk of Fusarium keratitis. The observations from the FDA inspection, which may indicate deviations from current good manufacturing practice, do not necessarily support a connection between the formulation of the ReNu with MoistureLoc product and the Fusarium keratitis infections.

It is important to point out FDA's inspectional observations are preliminary and will need to be further evaluated before any conclusions can be drawn about such a connection. It is premature to conclude that some of the observations cited in the report are associated with the cases of Fusarium keratitis. Once the Establishment Inspection Report (EIR) will be written, and documentation reviewed, FDA will be in a better position to evaluate its options.