Bausch & Lomb Plant Clears FDA Inspection

Contact lens solution plant made company's Renu with MoistureLoc solution, discontinued last year after it was connected to several hundred cases of a dangerous eye infection.

GREENVILLE, S.C. (AP) - Bausch & Lomb's contact lens solution plant here has cleared inspection by federal regulators, the Food and Drug Administration said Thursday.

The plant had made the company's Renu with MoistureLoc solution that was discontinued last year after it was connected to several hundred cases of a rare, but dangerous eye infection called Fusarium keratitis in parts of Asia and the United States.

The FDA inspected the plant last year and found several problems with production, including failure to properly test solutions and check suppliers. The government also said Bausch & Lomb failed to disclose links between the infection and its product discovered in Asia before the U.S. recall.

The FDA ruled out problems in the manufacturing process as contributing to the eye infections, Bausch & Lomb spokesman Michael L. McDougall said.

In March, the company recalled about 1.5 million bottles of its ReNu MultiPlus, also made at the Greenville plant, because trace amounts of iron could cause the cleaner to lose effectiveness earlier than normal.

No one was reported hurt in that recall.

McDougall said some of the corrections made to the Greenville plant's processes include putting stainless steel surfaces in the mix room, adding more quality control staff and installing new air conditioning equipment.

The FDA said the plant passed inspection June 29.

The company employs about 500 workers at its Greenville plant, McDougall said.

The Rochester, N.Y.-based company also makes contact lenses and other eye care products.

Bausch & Lomb accepted an offer of $65 in cash per share from private equity firm Warburg Pincus on May 16, but last week received a rival bid from Advanced Medical Optics of $75 per share in cash and stock, totaling $4.2 billion.

McDougall said the board has reaffirmed its acceptance of the offer from Warburg Pincus, but that it continues to have talks with Advanced Medical Optics.

More in Operations