CEPH International Replies to FDA Warning Letter

October 6, 2005
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

CEPH International Replies to FDA Warning Letter

Patheon Inc. (Mississauga, ON, Canada) announced this morning that its CEPH International subsidiary has filed a response to the US Food and Drug Administration’s Sept. 16 warning letter (see last week’s ePT).

After receiving the warning, CEPH suspended production of the oral suspension versions of the “Omnicef” powder products. The company reports that “CEPH, with the assistance of experts from Patheon, its client, and external consultants, worked diligently to analyze the issues raised by the FDA and to develop an enhanced process-improvement program to address the FDA's concerns. CEPH is currently implementing process improvements consistent with the program outlined in the response letter to the FDA.”

The company said that it anticipates resuming normal production in the first quarter of 2006, though the actual timing depends on the FDA’s response.

–Douglas McCormick