Sicor’s Irvine Unit Resolves Concerns Raised by FDA

Sicor Inc. said Thursday that it has resolved Food and Drug Administration officials’ concerns over problems at a company facility in Irvine.

Sicor’s Gensia Sicor Pharmaceuticals Inc. unit said in July that it had received a warning letter asking it to improve its record keeping concerning the cleaning of tanks used to mix drugs and to improve its procedures for backing up computer information.

The FDA is satisfied with the steps Sicor took, and the warning-letter issue is resolved, the company said.

Sicor also said it had won FDA approval to sell a generic version of Norcuron, an injectable drug used with anesthetics made by Dutch drug firm Akzo Nobel NV’s Organon unit.

The company’s stock closed Thursday at $3.97, up 34 cents a share.

The FDA sends hundreds of warning letters to companies each year, and only a fraction result in any significant agency action.