BAUSCH & LOMB STILL HAS LENS SOLUTION PROBLEMS, FDA SAYS
Bausch & Lomb's MoistureLoc contact lens solution was cited as "adulterated" in a recent FDA warning letter, which followed an agency inspection that found the firm did not conform to good manufacturing practice requirements.
Although a facility inspection March 22May 15 focused on the contact lens solution, the FDA's Oct. 31 letter said the inspection "nonetheless identified and documented significant [quality system] regulation violations that were systemic and are relevant to all products manufactured at the Greenville, S.C., facility." The agency did point out that there were no problems with other products manufactured at the same facility that warranted a recall or field correction.
In April, Bausch & Lomb voluntarily recalled its ReNu MoistureLoc contact lens solution in the U.S., after the FDA released a public health notice about an outbreak of Fusarium keratitis related to contact lens products. The fungal infection can cause eye damage and blindness. Bausch & Lomb expanded its recall worldwide in May.
Also in May, the FDA issued the firm a Form 483 citing 20 violations. "We acknowledge your efforts to address the outstanding inspection deficiencies," the FDA letter stated.
However, the agency did find problems. For example, Bausch & Lomb did not regularly audit suppliers or laboratories that tested raw materials and finished products, the letter said.