On November 6, 2006, the Food and Drug Administration (FDA) released a warning letter it sent to Bausch & Lomb Inc. after it found violations in the company’s Greenville, SC plant. The FDA inspected the plant following reports that some users of Bausch & Lomb’s ReNu with MoistureLoc contact-lens solution contracted a rare eye infection, Fusarium keratitis.

Bausch & Lomb announced a world-wide recall of the cleaning solution in May 2006 after announcing the product’s formulation, when combined with certain patient use patterns, may lead to an increase in risk of Fusarium keratitis, a fungal eye infection that can lead to blindness. The company is now facing product liability lawsuits related to the case.

The FDA’s letter followed an inspection of the company’s plant, and said that while it did not find any conditions that may have contributed to or caused the infection, it did find “numerous other manufacturing problems” that are systemic and related to all products manufactured in the facility.

Some of the problems identified include:

• Failure to establish and maintain procedures that ensure a device’s design include a way to address incomplete, unclear or conflicting requirements
• Failure to establish and maintain procedures to prevent the contamination of equipment or products that may have an unfavorable effect on product quality
• Failure to establish and maintain procedures to efficiently control environmental conditions, such as temperature conditions
• Failure to ensure that all equipment used in the plant to manufacture products meets specifications
• Failure to document maintenance activities
• Failure to review, evaluate and investigate complaints involving the possible failure of a device labeling or packaging, including complaints relating to the ReNu with MoistureLoc Multi-Purpose solution that is believed to be linked to the eye infection

There have been 164 confirmed cases of Fusarium infections in 33 states and one US territory. 60 percent of the cases involved a patient reportedly using ReNu with MoistureLoc.

The FDA gave Bausch & Lomb 15 days to submit a plan for correcting the violations. Also in the warning letter, the FDA said it found no evidence of clinical problems relating to any other Bausch & Lomb products.

Sources: US Food and Drug Administration Warning Letter, October 31, 2006; Patricia Kowsmann, “FDA warns Bausch & Lomb on lens-solution infections,” Wall Street Journal, November 7, 2006; Ben Rand, “Bausch & Lomb gets warning from FDA on plant,” Rochester Democrat and Chronicle, November 7, 2006.