Warning: CEPH International

September 29, 2005

ePT--the Electronic Newsletter of Pharmaceutical Technology

Warning: CEPH International

On Sept. 13, the US Food and Drug Administration’s San Juan (PR) District office sent a warning letter to CEPH International Corp. (Caguas, PR), acquired by Patheon (Mississauga, ON, Canada) in 2004 in its purchase of Mova Corporation. The letter, posted on FDA’s Web site on Sept. 27, cites the facility for failing to control and correct out-of-specification fill weights for certain versions of the "Omnicef OP" oral suspensions it manufactures under contract.

A Sept. 27 Patheon press release said, “As indicated in the Warning Letter, the affected product is powder for oral suspension, Omnicef OP 250 mg/5mL and 125 mg/5mL. The issues identified in the Warning Letter affect all manufacturing lines for the powder for oral suspension product. The capsule product is not affected.

“Patheon and CEPH are working diligently with their client to resolve the issues identified by the FDA in the Warning Letter. CEPH has decided to voluntarily suspend production of the powder product while it resolves these matters. Patheon and CEPH are committed to working expeditiously to resolve these issues so as to avoid interruption of supply of the product for the client."

–Douglas McCormick