FDA Warning Letter Cites Omnicef Contract Manufacturer For GMP Violations
This article was originally published in The Pink Sheet Daily
Executive Summary
Despite an effect on supply, Abbott said Omnicef oral suspension will remain available for patients who rely on the antibiotic.
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Abbott's supply of the antibiotic Omnicef (cefdinir) oral suspension will be affected by GMP violations at third-party manufacturer CEPH International's Puerto Rico facility, the brand company said. Abbott has sent staff to CEPH's 230,000 sq. ft. facility to address concerns regarding manufacturing problems and to ensure that the antibiotic is available for patients who rely on the medication, Abbott said Sept. 27. FDA cited the facility in a Sept. 13 FDL-1 warning letter for "out-of-specification results due to either low or high fill weight variations" of the product, as seen during an inspection between March 21 and April 22. The agency had noted "similar deficiencies" in 2003. The warning letter also cites the company for failing to implement "the appropriate corrective actions to assure the quality of each unit being distributed." FDA notes CEPH's "decision to cease manufacturing Omnicef OP 125mg/5mL and 250mg/5mL [in a] 30mL presentation until the new equipment (filling line) is qualified." "However, this corrective action fails to address similar deficiencies documented for the 60mL and 100mL presentations of this product in either strength." FDA said that 13 Omnicef lots of varying doses and volumes were subject to the warning letter. Four additional lots were also subject to ongoing investigations, the warning letter stated. CEPH also supplies Omnicef 300 mg capsules for adult use, although supply of that product is not in question and not included in the scope of the warning letter. FDA also said that the company failed to investigate and respond to post-marketing adverse event reports that "stated lack of effectiveness, and could possibly relate to incidents of the drug product failing to meet assay and/or fill weight specifications." Abbott said that CEPH is the only contract manufacturer supplying the company with Omnicef. CEPH International is a subsidiary of Mova Pharmaceuticals, which was acquired by Canadian-based contract manufacturer Patheon in December 2004 (1 (Also see "Patheon Broadens Its Pharma Client Base With Mova Acquisition" - Pink Sheet, 23 Nov, 2004.)). Patheon has "taken several actions, including purchasing new equipment, which is currently under validation," the firm said in a Sept. 19 press release. The company has 15 working days to respond to the warning letter with its plans for corrective actions. - Christopher Hollis |