Abbott Medical Optics responds to FDA warning of cleaning validation

In response to an FDA warning of cleaning validation at one of its plants, Abbott Medical Optics said problematic manufacturing processes were restricted to production of its ophthalmic viscosurgical device, 3% sodium hyaluronate, which is no longer being made or sold.

Santa Ana, CA-In response to an FDA warning about cleaning validation at one of its plants, Abbott Medical Optics (AMO) said problematic manufacturing processes were restricted to production of its ophthalmic viscosurgical device (OVD), 3% sodium hyaluronate (Healon D), which is no longer being made or sold.

The FDA warned the company Sept. 18 that the plant in Uppsala, Sweden, had failed to perform and document equipment cleaning validation for the production of the OVD. The warning was posted Dec. 14 on the FDA's Web site.

AMO told the FDA in October that it did not intend to complete the cleaning validation for 10 to 15 months, because it is no longer manufacturing or selling the particular OVD, said Steve Chesterman, AMO director, public affairs/communications. The delay was a result of a pending root cause investigation related to the Oct. 30, 2008, recall of the OVD, lot UD30654.

"Given the serious nature of the violation … [3% sodium hyaluronate] ophthalmic viscoelastic devices manufactured by your firm … appear to be adulterated," said Timothy A. Ulatowski, FDA's director of compliance, in his letter to AMO. "As a result FDA may take steps to refuse these products … until these violations are corrected."

He added that re-inspection of the plant may be necessary.

The plant, which AMO purchased in 2004, began global production of 3% sodium hyaluronate in the second quarter of 2008, in time for the European launch of the OVD, Chesterman said. However, according to the FDA, some syringes from a batch of the product made during September 2008 contained endotoxin levels above the allowable limit, prompting a Class I recall of that lot. Some 66 adverse reactions were reported, including cases of toxic anterior segment syndrome.

In April 2009, AMO announced it would halt production of the OVD, and it is no longer being manufactured or sold, Chesterman said.

"This doesn't [affect] any other Healon product, and AMO continues to provide an extensive line of Healon products globally," he added.