FDA Warning Letter to Bausch & Lomb

On October 31, 2006, the Food and Drug Administration issued a warning letter to Bausch & Lomb concerning its ReNu with MoistureLoc contact lens solution.
renu contact lens
The letter summarized the findings of the FDA’s inspections of the Greenville, South Carolina plant where ReNu with MoistureLoc was manufactured. The FDA inspected Bausch & Lomb’s plant from March 22, 2006 to May 15, 2006 after ReNu with MoistureLoc was linked with an outbreak of the fungal eye infection Fusarium keratitis. After hundreds of ReNu with MoistureLoc users in the United States, Asia and Europe began to exhibit Fusarium keratitis symptoms, Bausch & Lomb issued a worldwide ReNu recall in May 2006.
The FDA’s letter criticized Bausch & Lomb for several failures leading up to the ReNu recall, including:

    •  Failure to conduct sterility or infection testing on bottles of
       ReNu with MoistureLoc after cases of Fusarium keratitis
       symptoms were reported among users in Asia. The FDA
       says that Bausch & Lomb’s response to the Fusarium
       keratitis outbreak before the ReNu recall was “inadequate.”
  
    •  Failure to send a report to the FDA within 30 days of learning
       of the Asian Fusarium keratitis outbreak.  The FDA says that
       Bausch & Lomb received reports from officials in Singapore
       of Fusarium keratitis symptoms among 35 ReNu users, but
       failed to report these promptly to the agency.

   •  The company failed to conduct documented reviews of design
       results at several stages of development to ensure that products
       are being manufactured correctly. Specifically, the FDA says that
       Bausch & Lomb failed to conduct a “post-launch product review”
       for ReNu with MoistureLoc during the first year after its release.

Additionally, the FDA faulted Bausch & Lomb for several quality control issues at the Greenville plant, including:

   •  Bausch & Lomb’s failure to establish procedures to prevent the
      contamination of equipment.

   •  The company did not address several outstanding concerns
       raised about ReNu with MoistureLoc, including failure to
       conduct tests that show that it effectively kills “clinically
       significant microorganisms” such as the Fusarium keratitis fungus.

   •  Bausch & Lomb’s failure to establish a plan for auditing its
      quality control system. This quality control system includes
      the company’s complaint handling system and audits of
      suppliers of raw materials for Bausch & Lomb products,
      including ReNu with MoistureLoc.

   •  The company failed to adequately control environmental
      conditions in the area where contact lens solutions are produced.

   •  Bausch & Lomb failed to ensure that all manufacturing
      equipment meets FDA construction, cleaning and maintenance
      regulations.