Patheon, CEPH Begin Corrective Action Program for Omnicef OP

Patheon Inc. (Toronto, ON, Canada, www.patheon.com) and its subsidiary CEPH International Corporation (Caguas, PR) have begun a corrective action program to address concerns raised in a warning letter issued Sept. 16 for the company’s "Omnicef OP" powder for oral suspension product.

Initiation of the program follows this week’s positive reply from the US Food and Drug Administration to the companies’ Oct. 6 response letter, which outlined the corrective action plan.

Issued by FDA’s San Juan, Puerto Rico District office on Sept. 13, 2005, the warning letter affected all manufacturing lines for the powder for oral suspension form of Omnicef OP 250mg/5mL and 125 mg/5mL. The capsule product was not affected. Patheon and CEPH voluntarily suspended production of the powder product while they worked to resolve the issues identified by the agency.

According to a company announcement, CEPH expects to begin manufacturing qualification and validation batches of the Omnicef oral powder for suspension “in the next few days.” The company plans to perform qualification and validation testing of these batches in early November and, subject to satisfactory test results, will release these batches to its client. Moreover, in November, CEPH hopes to be in a position to notify FDA that production has been reinitiated and that it will be prepared for an FDA reinspection to verify the implementation of the corrective actions.