Manufacturing observations noted, FDA reports

The FDA, which was investigating Bausch & Lomb's Greenville, SC, plant in an effort to find some link to a possible contamination of the company's ReNu with MoistureLoc product manufactured there, announced May 16 it had uncovered several points where Bausch & Lomb had deviated from good manufacturing practices. However, the FDA said these points did not appear related to the Fusarium keratitis outbreak.

In their May 15 report, FDA investigators outlined 20 "objectionable conditions" at the plant, which they had inspected beginning March 22. The "observations" include an incomplete design plan for ReNu with MoistureLoc that would provide clear traceability through the design of the product, and a failure to perform design reviews at appropriate times. The FDA criticized the company for failing to notify the agency of 35 serious injury reports of Fusarium keratitis from Singapore in February 2006 relating to the MoistureLoc solution.

"None of the complaints was reported to the agency as of April 7," the report stated. However, Bausch & Lomb reputed the point, maintaining that it did notify the FDA "promptly and directly" about any Fusarium keratitis reports it received.

"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," the FDA said in a press release. The FDA said the investigators' report is being reviewed and an Establishment Inspection Report (EIR) will be written before the agency could evaluate its options.

FDA spokeswoman Kristen Neese said the inspectors' observations would be "internally vetted" at the agency, and the valid points reviewed with senior managers at Bausch & Lomb before the EIR is produced. The EIR is not a public document and will not be available for review, she said. Any potential warnings or recommendations would only come after this evaluation process is exhausted, although Neese cautioned that is not being considered at this point. She said Bausch & Lomb officials have been "very, very, very helpful" and "very cooperative" throughout the process.

In a May 16 press release, the company said it is working with the agency to address the inspectors' observations at the Greenville, SC, facility and will "take immediate, appropriate corrective actions." However, the company emphasized that none of the observations was related to the Fusarium keratitis outbreak.

"Bausch & Lomb is committed to continuous improvement in its operations and to maintaining its operations in compliance with all regulatory requirements and good manufacturing practices," the company said.