Bausch & Lomb Receives Warning from FDA over Handling of ReNu with MoistureLocNov 6, 2006 | Newsinferno.com
In a press release this morning, Rochester, New York-based Bausch & Lomb calls itself “the eye health Company, dedicated to perfecting vision and enhancing life for consumers around the world.” However, regulators at the U.S. Food and Drug Administration may not agree. Last week, the FDA sent a rather incriminating warning letter to the company, chastising them for neglecting to report nearly three dozen cases of severe fungal eye infections connected to its ReNu with MoistureLoc contact lens solution.
The letter also cited numerous violations stemming from a two-month investigation of Bausch’s Greenville, South Carolina, facility this past spring. Referring to Bausch’s contact lens solutions, the FDA said that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements.”
According to the October 31 warning letter, the company failed to inform the FDA of “35 serious injury reports of Fusarium keratitis from Singapore’s Minister of Health in February 2006 relating to ReNu with MoistureLoc Multi-Purpose Solution. None of the complaints were reported to the Agency as of April 7, 2006,” as required by law.
The company suspended Asian sales of ReNu with MoistureLoc in February and U.S. sales in April before eventually issuing a global recall on May 15. The spring FDA inspection did not directly connect any of the violations with the spread of Fusarium keratitis. However, the letter claimed that Bausch failed to thoroughly investigate the issues related to Fusarium keratitis. Bausch “did not include sterility or biocidal testing for ReNu with MoistureLoc Multi-Purpose Solution product lots implicated in complaints received from Hong Kong” and “had not performed sterility testing on the returned/retain samples in conjunction with the Fusarium investigation for complaints received from Malaysia and Singapore.”
Bausch has 15 days from the date of the letter to respond to the allegations. “Failure to promptly correct these violations,” says the FDA, “may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.”